Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older.
None.
None.
Clotrimazole and betamethasone dipropionate cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. ( 5.1, 8.4) Pediatric patients may be more susceptible to systemic toxicity. ( 5.1, 8.4) The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended. ( 5.2) Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.3)
Treatment of tinea corporis or tinea cruris: Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 2 weeks. Treatment of tinea pedis: Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application.
Cream, 1%/0.05%. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg of clotrimazole and 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a smooth white cream base.
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is a smooth white cream and supplied in: 15-gram tube NDC 80425-0344-01 Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308714 | clotrimazole 1 % / betamethasone 0.05 % Topical Cream | PSN | 2 |
| 308714 | betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream | SCD | 2 |
| 308714 | betamethasone 0.05 % / clotrimazole 1 % Topical Cream | SY | 2 |
| 308714 | betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BETAMETHASONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| dde7b902-54a1-627e-12f1-9e6d244ab88c | Product name | 4 | 20250317 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 69b49899-11cf-4f7e-bd0a-7dc93b27311b | Product name | 3 | 20250130 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| bbdc14c7-d940-43b5-a2f7-36c425991f3c | Product name | 1 | 20240320 |
| 0a2fcc35-464b-9ec2-a622-753662cdd48c | Product name | 3 | 20240216 |
| 6f762601-17ef-4321-8f47-77783d3c4d8b | Product name | 3 | 20231116 |
| 1dbefad7-ab34-69c3-e51a-e7148aa38f70 | Product name | 5 | 20220921 |
| 7fea2046-07a9-4bb6-9409-828ac6f1f6df | Product name | 1 | 20210201 |
| f059f1a2-0e64-4839-9a7f-42687c91a44b | Product name | 1 | 20201007 |
| 4ea9e4b5-b452-48ad-9b25-b9a4d403405d | Product name | 1 | 20160310 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 4f07db9b-3707-3e2c-05b5-d7852ba808c4 | Product name | 1 | 20140508 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0344-1 | Clotrimazole and Betamethasone Dipropionate | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 80425-0344-1 | Clotrimazole and Betamethasone Dipropionate | 15 g in 1 TUBE | CREAM | 15 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0344 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 2 package rows | 20250102_fe2ec7d2-23c2-e99f-e053-6294a90aa65a.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0344-1 | GM - Gram | 80425-0344 | a79c20cd-f149-4609-9af4-268e6954d9b5 | 1 | 2023-07-06 |
| 51672-4048-1 | GM - Gram | 51672-4048 | c296ef7d-318c-4909-bbd9-9c27f97b32f4 | 1 | 2012-07-24 |
| 51672-4048-6 | GM - Gram | 51672-4048 | 507ea9d3-d81a-48e1-8891-3ed8a4729278 | 1 | 2012-07-24 |
| Product NDC | Package NDC |
|---|---|
| 80425-0344 | 80425-0344-1 |
| 51672-4048 |
| Name | UNII | Kind |
|---|---|---|
| CETEARETH-30 | 1R9DCZ5FOX | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CLOTRIMAZOLE | G07GZ97H65 | ACTIB |
| BETAMETHASONE DIPROPIONATE | 826Y60901U | ACTIM |
Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older.
Treatment of tinea corporis or tinea cruris: Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 2 weeks. Treatment of tinea pedis: Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application.
Cream, 1%/0.05%. Each gram of clotrimazole and betamethasone dipropionate cream contains 10 mg of clotrimazole and 0.64 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a smooth white cream base.
None.
Clotrimazole and betamethasone dipropionate cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. ( 5.1, 8.4) Pediatric patients may be more susceptible to systemic toxicity. ( 5.1, 8.4) The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended. ( 5.2) Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.3)
Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. Chemically, clotrimazole is 1–(o-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C 22 H 17 CLN 2 , 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 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , 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 cream contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative.
In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the first return visit than subjects treated with clotrimazole cream. In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with clotrimazole and betamethasone dipropionate cream were as good as, or better than, in those subjects treated with clotrimazole cream. In these same clinical studies, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is a smooth white cream and supplied in: 15-gram tube NDC 80425-0344-01 Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform the patient of the following:
Mfd by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Revised: October 2019 78428-1019-7 89
Patient Information Clotrimazole (kloe trim' a zole) and Betamethasone Dipropionate (bay" ta meth' a sone dye proe' pee oh nate) Cream USP, 1%/0.05% Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina. What is clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older. Clotrimazole and betamethasone dipropionate cream is used for fungal infections that are inflamed and have symptoms of redness or itching. Clotrimazole and betamethasone dipropionate cream should not be used in children under 17 years of age. Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if clotrimazole and betamethasone dipropionate cream will harm your unborn baby. If you use clotrimazole and betamethasone dipropionate cream during pregnancy, use clotrimazole and betamethasone dipropionate cream on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if clotrimazole and betamethasone dipropionate cream passes into your breast milk. Breastfeeding women should use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid contact with your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. How should I use clotrimazole and betamethasone dipropionate cream? Use clotrimazole and betamethasone dipropionate cream exactly as your healthcare provider tells you to use it. Use clotrimazole and betamethasone dipropionate cream for the prescribed treatment time, even if your symptoms get better. Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream in 1 week. Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use clotrimazole and betamethasone dipropionate cream in the groin area. Do not use clotrimazole and betamethasone dipropionate cream on your face or underarms (armpits). For treatment of fungal infections of the groin and body: Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 1 week. Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment. Do not use clotrimazole and betamethasone dipropionate cream for longer than 2 weeks. For treatment of fungal infections of the feet: Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 2 weeks. Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment. Do not use clotrimazole and betamethasone dipropionate cream longer than 4 weeks. Wash your hands after applying clotrimazole and betamethasone dipropionate cream. What should I avoid while using clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream should not be used to treat diaper rash or redness. You should avoid applying clotrimazole and betamethasone dipropionate cream in the diaper area. What are the possible side effects of clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream may cause serious side effects, including: Clotrimazole and betamethasone dipropionate cream can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems. Vision problems. Topical corticosteroids may increase your chance of developing cataracts and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clotrimazole and betamethasone dipropionate cream. The most common side effects of clotrimazole and betamethasone dipropionate cream include burning, tingling, rash, swelling, and infections. These are not all the possible side effects of clotrimazole and betamethasone dipropionate cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store clotrimazole and betamethasone dipropionate cream? Store clotrimazole and betamethasone dipropionate cream at room temperature between 68°F to 77°F (20°C to 25°C). Keep clotrimazole and betamethasone dipropionate cream and all medicines out of the reach of children. General information about the safe and effective use of clotrimazole and betamethasone dipropionate cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clotrimazole and betamethasone dipropionate cream for a condition for which it was not prescribed. Do not give clotrimazole and betamethasone dipropionate cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clotrimazole and betamethasone dipropionate cream that is written for health professionals. What are the ingredients in clotrimazole and betamethasone dipropionate cream? Active ingredients: clotrimazole and betamethasone dipropionate Inactive ingredients: ceteareth-30, cetostearyl alcohol, mineral oil, phosphoric acid, propylene glycol, purified water, sodium phosphate monobasic monohydrate, white petrolatum; benzyl alcohol as preservative For more information, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or www.taro.com. Mfd by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: October 2019 78428-1019-7 89 This Patient Information has been approved by the U.S. Food and Drug Administration.