Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent th...
Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected skin areas twice a day, in the morning and evening. Clotrimazole and betamethasone dipropionate lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient w...
www.fda.gov/medwatchRx Only
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.
Clotrimazole and betamethasone dipropionate lotion contains combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.
Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl)imidazole, with the empirical formula C22H17CIN2, a molecular weight of 344.84, and the following structural formula:
Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.
Betamethasone dipropionate has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Each gram of clotrimazole and betamethasone dipropionate lotion contains 10 mg clotrimazole and 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic base of purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid (used for pH adjustment, if required); benzyl alcohol as a preservative. Clotrimazole and betamethasone dipropionate lotion is opaque and white in color.
No comparative studies have been conducted with clotrimazole and betamethasone dipropionate lotion and clotrimazole alone. Use of corticosteroids in the treatment of a fungal infection may lead to suppression of host inflammation leading to worsening or decreased cure rate.
Skin penetration and systemic absorption of clotrimazole following topical application of clotrimazole and betamethasone dipropionate lotion have not been studied. The following information was obtained using 1% clotrimazole cream and solution formulations. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm3 in the stratum corneum, to 0.5 to 1 mcg/cm3 in the reticular dermis, and 0.1 mcg/cm3 in the subcutis. No measurable amount of radioactivity (<0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution. Only 0.5% or less of the applied radioactivity was excreted in the urine.
Microbiology
Mechanism of Action: Clotrimazole is an imidazole antifungal agent. Imidazoles inhibit 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi.
Activity In Vivo: Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum.
Activity In Vitro: In vitro, clotrimazole has been shown to have activity against many dermatophytes, but the clinical significance of this information is unknown.
Drug Resistance: Strains of dermatophytes having a natural resistance to clotrimazole have not been reported.
Resistance to azoles including clotrimazole has been reported in some Candida species. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes.
Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. (See DOSAGE AND ADMINISTRATION section). Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. (See DOSAGE AND ADMINISTRATION section).
Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Studies performed with clotrimazole and betamethasone dipropionate lotion indicate that this topical combination anti-fungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high potency topical corticosteroids. Therefore use is not recommended in patients less than 17 years of age, in diaper dermatitis, and under occlusion.
In the treatment of tinea pedis twice daily for 4 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in relieving symptoms of erythema, scaling, pruritus, and maceration at week 2.
Clotrimazole and betamethasone dipropionate lotion was also shown to have a superior mycological cure rate compared to vehicle 2 weeks after discontinuation of treatment. It is unclear if the relief of symptoms at 2 weeks in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.
In the treatment of tinea cruris twice daily for 2 weeks, clotrimazole and betamethasone dipropionate lotion was shown to be superior to vehicle in the relief of symptoms of erythema, scaling, pruritus after 3 days. It is unclear if the relief of symptoms after 3 days in this clinical study with clotrimazole and betamethasone dipropionate lotion was due to the contribution of betamethasone dipropionate, clotrimazole, or both.
The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion versus clotrimazole alone in a lotion vehicle have not been studied in the treatment of tinea pedis or tinea cruris or tinea corporis. The comparative efficacy and safety of clotrimazole and betamethasone dipropionate lotion and clotrimazole and betamethasone dipropionate cream have also not been studied.
Clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate lotion for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established.
Clotrimazole and betamethasone dipropionate lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.
General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Conditions which augment systemic absorption include use over large surface areas, prolonged use, and use under occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. Patients applying clotrimazole and betamethasone dipropionate lotion to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, morning plasma cortisol, and urinary free cortisol tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
In a small study, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (BID) to the crural of normal adult subjects. Three of the eight normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment period. One of these subjects had an abnormal Cortrosyn test.
The effect on morning plasma cortisol was transient and subjects recovered one week after discontinuing dosing. In addition, two separate studies in pediatric patients demonstrated adrenal suppression as determined by cosyntropin testing (See PRECAUTIONS – Pediatric Use).
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (See PRECAUTIONS – Pediatric Use).
If irritation develops, clotrimazole and betamethasone dipropionate lotion should be discontinued and appropriate therapy instituted.
THE SAFETY OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION HAS NOT BEEN DEMONSTRATED IN THE TREATMENT OF DIAPER DERMATITIS. ADVERSE EVENTS CONSISTENT WITH CORTICOSTEROID USE HAVE BEEN OBSERVED IN PATIENTS TREATED WITH CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM FOR DIAPER DERMATITIS. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION IN THE TREATMENT OF DIAPER DERMATITIS IS NOT RECOMMENDED.
Information for Patients: Patients using clotrimazole and betamethasone dipropionate lotion should receive the following information and instructions:
Laboratory Tests: If there is a lack of response to clotrimazole and betamethasone dipropionate lotion, appropriate confirmation of the diagnosis, including possible mycological studies, is indicated before instituting another course of therapy.
The following tests may be helpful in evaluating HPA axis suppression due to the corticosteroid components:
Urinary free cortisol test, Morning plasma cortisol test, ACTH stimulation test
Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis.
Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.
Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the maximum human dose based on body surface areas, respectively.
In a combined study of the effects of clotrimazole on fertility, teratogenicity, and postnatal development, male and female rats were dosed orally (diet admixture) with levels of 5, 10, 25 or 50 mg/kg/day (approximately 1-8 times the maximum dose in a 60 kg adult based on body surface area) from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.
Pregnancy: Teratogenic Effects: Category C: There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels.
Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum human dose) revealed no evidence of fetotoxicity due to clotrimazole exposure.
No increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation days 6-15. However, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights) and maternally toxic (reduced body weight gain) to rats. Clotrimazole dosed at 200 mg/kg/day (30 times the maximum human dose) was maternally lethal, and therefore fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses. However, in the combined fertility, teratogenicity, and postnatal development study described above, 50 mg/kg clotrimazole, was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks.
Oral clotrimazole doses of 25, 50, 100 and 200 mg/kg/day (2-15 times the maximum human dose) were not teratogenic in mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day (18-55 times the maximum human dose).
Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele and cleft palates.
Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.
There are no adequate and well-controlled studies in pregnant women of the teratogenic effects of topically applied corticosteroids. Therefore, clotrimazole and betamethasone dipropionate lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole and betamethasone dipropionate lotion is administered to a nursing woman.
Pediatric Use: Adverse effects consistent with corticosteroid use have been observed in patients under 12 years of age treated with clotrimazole and betamethasone dipropionate cream. In open-label studies, 17 of 43 (39.5%) evaluable pediatric patients (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label study, 8 of 17 (47.1%) evaluable pediatric patients (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION IN THE TREATMENT OF PATIENTS UNDER 17 YEARS OF AGE OR PATIENTS WITH DIAPER DERMATITIS IS NOT RECOMMENDED.
Because of higher ratio of skin surface to body mass, pediatric patients under the age of 12 years are at higher risk with clotrimazole and betamethasone dipropionate lotion. The studies described above suggest that pediatric patients under the age of 17 years may also have this risk. They are at increased risk of developing Cushing's syndrome while on treatment and adrenal insufficiency after withdrawal of treatment. Adverse effects, including striae and growth retardation, have been reported with inappropriate use of clotrimazole and betamethasone dipropionate cream in infants and children. (See PRECAUTIONS and ADVERSE REACTIONS).
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Geriatric Use: Clinical studies of clotrimazole and betamethasone dipropionate lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Caution should be exercised with the use of these corticosteroid containing topical products on thinning skin. THE USE OF CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION UNDER OCCLUSION, SUCH AS IN DIAPER DERMATITIS, IS NOT RECOMMENDED.
Adverse reactions reported for clotrimazole and betamethasone dipropionate lotion in clinical trials were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients.
The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product).
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.
Amounts greater than 45 mL/week of clotrimazole and betamethasone dipropionate lotion should not be used. Acute overdosage with topical application of clotrimazole and betamethasone dipropionate lotion is unlikely and would not be expected to lead to life-threatening situation. Clotrimazole and betamethasone dipropionate lotion should not be used for longer than the prescribed time period.
Topically applied corticosteroids, such as the one contained in clotrimazole and betamethasone dipropionate lotion can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected skin areas twice a day, in the morning and evening.
Clotrimazole and betamethasone dipropionate lotion should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after one week of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate lotion should not be used longer than 4 weeks in the treatment of tinea pedis, and amounts greater than 45 mL per week of clotrimazole and betamethasone dipropionate lotion should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate lotion, the diagnosis should be reviewed.
Clotrimazole and betamethasone dipropionate lotion should not be used with occlusive dressings.
Clotrimazole and betamethasone dipropionate lotion, 1%/0.05% (base) is supplied as follows
NDC 0168-0370-30 30 mL Bottle
Store at 25°C (77°F) in the upright position only; excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. SHAKE WELL BEFORE EACH USE.
I2370D
R12/15
#104
Remove this portion before dispensing
What is clotrimazole and betamethasone dipropionate lotion?
Clotrimazole and betamethasone dipropionate lotion is a medication used on the skin to treat fungal infections of the feet, groin, and body, as diagnosed by your doctor. Clotrimazole and betamethasone dipropionate lotion should be used for fungal infections that are inflamed and have symptoms of redness and/or itching. Talk to your doctor if your fungal infection does not have these symptoms. Clotrimazole and betamethasone dipropionate lotion contains a corticosteroid. Notify your doctor if you notice side effects with the use of clotrimazole and betamethasone dipropionate lotion. (see ``What are the possible side effects of clotrimazole and betamethasone dipropionate lotion?′′ below). Clotrimazole and betamethasone dipropionate lotion is not to be used in the eyes, in the mouth, or in the vagina.
How does clotrimazole and betamethasone dipropionate lotion work?
Clotrimazole and betamethasone dipropionate lotion is a combination of an antifungal agent (clotrimazole) and a corticosteroid (betamethasone dipropionate). Clotrimazole works against fungus. Betamethasone dipropionate, a corticosteroid, is used to help relieve redness, swelling, itching, and other discomforts of fungal infections.
Who should NOT use clotrimazole and betamethasone dipropionate lotion?
Clotrimazole and betamethasone dipropionate lotion is not recommended for use in patients under the age of 17 years. Clotrimazole and betamethasone dipropionate lotion is not recommended for use in diaper rash.
Patients who are sensitive to clotrimazole and betamethasone dipropionate, other corticosteroids or imidazoles or any ingredients in the preparation should not use clotrimazole and betamethasone dipropionate lotion.
How should I use clotrimazole and betamethasone dipropionate lotion?
Gently massage sufficient clotrimazole and betamethasone dipropionate lotion into the affected and surrounding skin areas twice a day, in the morning and evening. Treatment for 2 weeks on the groin or on the body, and for 4 weeks on the feet is recommended. The use of clotrimazole and betamethasone dipropionate lotion for longer than 4 weeks is not recommended for any condition. Prolonged use of clotrimazole and betamethasone dipropionate lotion may lead to unwanted side effects.
What other important information should I know about clotrimazole and betamethasone dipropionate lotion?
What are the possible side effects of clotrimazole and betamethasone dipropionate lotion?
The following side effects have been reported with topical corticosteroid medications: itching, irritation, dryness, infection of the hair follicles, increased hair, acne, fragile blood vessels, spider veins, sensitization (local reactions upon repeated application of product), change in skin color, allergic skin reaction, skin thinning, and stretch marks. Hormone imbalance (adrenal suppression) was demonstrated in clinical studies in children.
To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can clotrimazole and betamethasone dipropionate lotion be used if I am pregnant or plan to become pregnant or if I am nursing?
Before using clotrimazole and betamethasone dipropionate lotion, tell your doctor if you are pregnant or plan to become pregnant. Also, tell your doctor if you are nursing.
How should clotrimazole and betamethasone dipropionate lotion be stored?
Store at 25°C (77°F) in the upright position only; excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Shake well before using clotrimazole and betamethasone dipropionate lotion.
General advice about prescription medicines
This medication was prescribed for your particular condition. Only use clotrimazole and betamethasone dipropionate lotion to treat the condition for which your doctor has prescribed. Do not give clotrimazole and betamethasone dipropionate lotion to other people. It may harm them. Keep out of reach of children.
This leaflet summarizes the most important information about clotrimazole and betamethasone dipropionate lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about clotrimazole and betamethasone dipropionate lotion that is written for health professionals.
E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.,
Melville, New York 11747
R12/15
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML LABEL
Fougera®
FOR TOPICAL USE ONLY. NOT FOR
OPHTHALMIC, ORAL, OR INTRAVAGINAL
USE. NOT RECOMMENDED FOR PATIENTS
UNDER THE AGE OF 17 YEARS AND NOT
RECOMMENDED FOR DIAPER DERMATITIS.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML CARTON
Fougera®
FOR TOPICAL USE ONLY. NOT FOR
OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
NOT RECOMMENDED FOR PATIENTS UNDER
THE AGE OF 17 YEARS AND NOT
RECOMMENDED FOR DIAPER DERMATITIS.
Rx Only
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0370-30 | ML - Milliliter | 0168-0370 | 8733d935-63e5-4846-a861-5fb217a398a9 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | ACTIVE INGREDIENT | 826Y60901U | 5 | |
| CLOTRIMAZOLE | ACTIVE INGREDIENT | G07GZ97H65 | 5 | |
| BETAMETHASONE | ACTIVE MOIETY | 9842X06Q6M | 5 | |
| CLOTRIMAZOLE | ACTIVE MOIETY | G07GZ97H65 | 5 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 5 | |
| CETEARETH-30 | INACTIVE INGREDIENT | 1R9DCZ5FOX | 5 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 5 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 5 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 5 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0168-0370 | 0168-0370-30 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CLOTRIMAZOLE | G07GZ97H65 | ACTIB |
| BETAMETHASONE DIPROPIONATE | 826Y60901U | ACTIM |
| WATER | 059QF0KO0R | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CETEARETH-30 | 1R9DCZ5FOX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SOLUTION / ORAL | 1500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / VAGINAL | 1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | CREAM / VAGINAL | 0.56 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SUSPENSION / SOFT TISSUE | 13 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 11460 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / SOFT TISSUE | 40 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRA-ARTICULAR | 14 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 278 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | TABLET, FILM COATED / ORAL | 0.11 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 2829 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 6000 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION / INTRAMUSCULAR | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRAVASCULAR | 0.15 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | AEROSOL, FOAM / VAGINAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 201 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CAPSULE, EXTENDED RELEASE / ORAL | 1.23 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / SUBCUTANEOUS | 225 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SPRAY / NASAL | 5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | LOTION, AUGMENTED / TOPICAL | 14 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | CREAM / TOPICAL | 160 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 40 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SUSPENSION / INTRAVITREAL | 0.04 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 800 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRAMUSCULAR | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRAMUSCULAR | 120 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / ORAL | 10.06 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAMUSCULAR | 54 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | LOTION / TOPICAL | 8 mg | ||
| PHOSPHORIC ACID | PHOSPHORIC ACID | E4GA8884NN | LOTION, AUGMENTED / TOPICAL | 3 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 1.84 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / ORAL | 100 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 |
| Application-product | TE code |
|---|---|
| A076516-001 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076516-001 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE;1% | LOTION / TOPICAL | AB | 2005-06-16 | 3a93d1ddd44b… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076516-001 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A076516-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076516-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076516-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076516-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076516-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076516-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076516-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076516-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076516-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076516-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076516-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076516-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076516-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076516-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076516-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076516-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076516-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076516-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076516-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076516-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076516-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076516-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076516-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076516-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076516-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076516-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076516-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076516-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076516-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076516-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076516-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076516-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076516-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076516-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076516-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076516-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076516-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076516-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076516-001 | AB | 1 | 3a93d1ddd44b… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7f978675-9212-4ae5-affa-0d4f9d644e95 | 20ad6d8a-117a-4b9d-a14c-24234437e211 | 2015-12-15 | Adverse reactions | 20ad6d8a-117a-4b9d-a14c-24234437e211 |
Adverse event summaries are temporarily unavailable. Other product information remains available.