Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Terconazole Vaginal Cream 0.4%: One full applicator (5 g) of Terconazole Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Terconazole Vaginal Cream 0.8%: One full applicator (5 g) of Terconazole Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days. Before prescribing another ...
Terconazole Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.
Terconazole Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.
The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.
Following intravaginal administration of terconazole in humans, absorption ranged from 5–8% in three hysterectomized subjects and 12–16% in two non-hysterectomized subjects with tubal ligations.
Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to normal humans, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours.
Results from similar studies in patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy women. The absorption characteristics of terconazole 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in normal volunteers.
Following oral (30 mg) administration of 14C-labelled terconazole, the harmonic half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0–11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%. Total radioactivity was eliminated from the blood with a harmonic half-life of 52.2 hours (range 44–60). Excretion of radioactivity was both by renal (32–56%) and fecal (47–52%) routes.
In vitro, terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.
Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light.
Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream (0.4% and 0.8%).
Terconazole exhibits fungicidal activity in vitro against Candida albicans. Antifungal activity has also been demonstrated against other fungi. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥128 mcg/mL; therefore these beneficial bacteria were not affected by drug treatment.
The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by the disruption of normal fungal cell membrane permeability. No resistance to terconazole has developed during successive passages of C. albicans.
Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Patients known to be hypersensitive to terconazole or to any of the components of the cream.
None.
Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.
If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
Terconazole
Vaginal Cream 0.4%:
The therapeutic effect of this product
is not affected by oral contraceptive usage.
Terconazole Vaginal Cream 0.8%:
The
levels of estradiol (E2) and progesterone did not differ significantly when
0.8% terconazole vaginal cream was administered to healthy female volunteers
established on a low dose oral contraceptive.
Carcinogenesis:
Studies to determine
the carcinogenic potential of terconazole have not been performed.
Mutagenicity:
Terconazole was not
mutagenic when tested in vitro for induction of microbial
point mutations (Ames test), or for inducing cellular transformation, or in
vivo for chromosome breaks (micronucleus test) or dominant lethal
mutations in mouse germ cells.
Impairment of Fertility:
No
impairment of fertility occurred when female rats were administered terconazole
orally up to 40 mg/kg/day for a three month period.
Pregnancy Category C.
There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (50x the recommended intravaginal human dose of the 0.8% vaginal cream formulation, and 100x the intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.
Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.4% vaginal cream, and by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.8% vaginal cream. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.
Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and efficacy in children have not been established.
Clinical studies of terconazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Terconazole Vaginal Cream 0.4%:
During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Vulvovaginal burning (5.2%), itching (2.3%) or irritation (3.1%) occurred less frequently with terconazole 0.4% vaginal cream than with the vehicle placebo. Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo) have also been reported. The therapy-related dropout rate was 1.9%. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching (0.6%), which was lower than the incidence for placebo (0.9%).
Terconazole Vaginal Cream 0.8%:
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole 0.8% vaginal cream 3 day regimen (5% vs. 6%–9% with placebo). Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole 0.8% vaginal cream. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
Overdose of terconazole in humans has not been reported to date. In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≅1280 and ≥640 mg/kg, respectively.
Terconazole Vaginal Cream 0.4%:
One full applicator (5 g) of Terconazole Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.
Terconazole Vaginal Cream 0.8%:
One full applicator (5 g) of Terconazole Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.
Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of these products is not affected by menstruation.
Terconazole Vaginal Cream 0.4% is available in 45 g (NDC 0591-3196-89) tubes with a measured-dose applicator. Store at Controlled Room Temperature 15° - 30° C (59° - 86° F).
Terconazole Vaginal Cream 0.8% is available in 20 g (NDC 0591-3197-52) tubes with a measured-dose applicator. Store at Controlled Room Temperature 15° - 30° C (59° - 86° F).
| Mfd. for: Watson Laboratories, Inc. | Mfd. by: Draxis Specialty Pharmaceuticals Inc. |
JOLLC | |
| Printed in U.S.A. | Revised January 2010 |
TERCONAZOLE Vaginal Cream 0.4%
7–Day Regimen
TERCONAZOLE Vaginal Cream 0.8%
3–Day Regimen
PATIENT INSTRUCTIONS
Filling the Applicator:
Using the Applicator:
Cleaning the Applicator:
After each use, you should thoroughly clean the applicator by following the procedure below:
NOTE: Store the cream at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.
A WORD ABOUT YEAST INFECTIONS
Why Do Yeast Infections Occur?
Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.
Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.
How Can I Prevent Yeast Infections?
Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.
Controlling these factors can help eliminate yeast infections and may prevent them from coming back.
Some Other Helpful Tips:
| Mfd. for: Watson Laboratories, Inc. | Mfd. by: Draxis Specialty Pharmaceuticals Inc. |
JOLLC | |
| Printed in U.S.A. | Revised January 2010 |
NDC 55045-3259-03
PRINCIPAL DISPLAY PANEL
Terconazole Vaginal Cream
0.8%
Tube and Applicator
For Vaginal Use Only.
Rx only
Net Wt 0.71 oz. (20 g)
Quantity by weight not by volume.
| Class | Version | Type | Effective |
|---|---|---|---|
| TERCONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a1f2acc3-46a1-8c88-4468-5826c2e9fea6 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55045-3259-3 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d5f5-8e05-e053-dbdaa90a074a | TERCONAZOLE VAGINAL CREAM 0.4% 7-Day Regimen TERCONAZOLE VAGINAL CREAM 0.8% 3-Day Regimen |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55045-3259-3 | TERCONAZOLE | 20 g in 1 TUBE, WITH APPLICATOR | CREAM | 20 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55045-3259 | TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20110930_8e125228-4963-4a7b-a0e7-857e63496486.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3197-52 | GM - Gram | 0591-3197 | 6f0e3b2d-c18b-44ac-a8d4-3b79603a3231 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TERCONAZOLE | ACTIVE INGREDIENT | 0KJ2VE664U | 1 | |
| TERCONAZOLE | ACTIVE MOIETY | 0KJ2VE664U | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55045-3259 | 55045-3259-3 |
| 0591-3197 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TERCONAZOLE | 0KJ2VE664U | ACTIM |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE, LIQUID FILLED / ORAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / TOPICAL | 0.98 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRA-ARTICULAR | 4 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 53 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ENEMA / RECTAL | 0.01 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | PASTE / ORAL | 28 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM, EXTENDED RELEASE / TRANSDERMAL | 20.4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | OINTMENT / TOPICAL | 0.1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TRANSDERMAL | 113 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / AURICULAR (OTIC) | 0.02 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ELIXIR / ORAL | 2.5 mg/15ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / VAGINAL | 0.03 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | OINTMENT / TOPICAL | 569 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE / ORAL | 418.37 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 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 |
|---|---|---|---|---|---|---|---|
| N019964-001 | TERAZOL 3 | TERCONAZOLE | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| bce76198-3fdc-482e-8c03-31fd4e134aeb | 8e125228-4963-4a7b-a0e7-857e63496486 | 2011-09-22 | Warnings, Adverse reactions | bce76198-3fdc-482e-8c03-31fd4e134aeb 8e125228-4963-4a7b-a0e7-857e63496486 |
Adverse event summaries are temporarily unavailable. Other product information remains available.