Clotrimazole and Betamethasone Dipropionate
Cream · Topical
Uses
Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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. Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a 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. ( 1 )
Dosage and administration
Treatment of tinea corporis or tinea cruris:
• Apply a thin film of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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, 1%/0.05% (base), 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, 1%/0.05% (base) 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, 1%/0.05% (base) the diagnosis should be reviewed.
• Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application.
• Tinea pedis : Apply a thin film to the affected skin areas twice a day for 2 weeks. Do not use longer than 4 weeks. ( 2 )
• Tinea cruris and tinea corporis : Apply a thin film to the affected skin area twice a day for 1 week. Do not use longer than 2 weeks. ( 2 )
• Do not use with occlusive dressings unless directed by a physician. ( 2 )
• Not for ophthalmic, oral or intravaginal use. ( 2 )
Dosage forms and strengths
Cream, 1%/0.05%. Each gram of clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole, USP and 0.64 mg of betamethasone dipropionate, USP (equivalent to 0.5 mg of betamethasone) in a white to off-white cream base.
• Cream, 1%/0.05%. ( 3 )
• Each gram of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) contains 10 mg of clotrimazole, and 0.64 mg of betamethasone dipropionate, (equivalent to 0.5 mg of betamethasone) in white to off-white cream base. ( 3 )
Contraindications
None.
• None. ( 4 )
Warnings and precautions
• Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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, 1%/0.05% (base) 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 ) 5.1 Effects on Endocrine System Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing's syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age. Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a small trial, clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was applied using large dosages, 7 g daily for 14 days (BID) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4) ] . If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios [see Use in Specific Populations (8.4) ] . 5.2 Diaper Dermatitis The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the treatment of diaper dermatitis is not recommended. 5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products, including topical betamethasone products [see Adverse Reactions (6.2) ]. Avoid contact of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
Side effects
Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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 Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 1% included rash, edema, and secondary infection. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products. Adverse reactions reported with the use of clotrimazole are: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.
Use in specific populations
8.1 Pregnancy Risk Summary There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy . Advise pregnant women that clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) on the smallest area of skin and for the shortest duration possible. There have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. In an animal reproduction study, betamethasone dipropionate caused malformations (i.e., umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by the intramuscular route during organogenesis [see Data]. The available data do not allow the calculation of relevant comparisons between the systemic exposure of clotrimazole and/or betamethasone dipropionate observed in the animal studies to the systemic exposure that would be expected in humans after topical use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Clotrimazole Studies in pregnant rats treated during organogenesis with intravaginal doses up to 100 mg/kg/day 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 to 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 was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day had no adverse effects on dams or fetuses. However, in the combined fertility, embryofetal development, and postnatal development study conducted in rats, 50 mg/kg/day clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks [see Nonclinical Toxicology (13.1) ]. Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day did not cause malformations in pregnant mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day. Betamethasone Dipropionate Betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates. 8.2 Lactation Risk Summary There are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) and any potential adverse effects on the breastfed infant from clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4) ] . 8.4 Pediatric Use The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in patients under 17 years of age is not recommended. Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base). In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy . Advise pregnant women that clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) on the smallest area of skin and for the shortest duration possible. There have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. In an animal reproduction study, betamethasone dipropionate caused malformations (i.e., umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by the intramuscular route during organogenesis [see Data]. The available data do not allow the calculation of relevant comparisons between the systemic exposure of clotrimazole and/or betamethasone dipropionate observed in the animal studies to the systemic exposure that would be expected in humans after topical use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Clotrimazole Studies in pregnant rats treated during organogenesis with intravaginal doses up to 100 mg/kg/day 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 to 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 was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day had no adverse effects on dams or fetuses. However, in the combined fertility, embryofetal development, and postnatal development study conducted in rats, 50 mg/kg/day clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks [see Nonclinical Toxicology (13.1) ]. Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day did not cause malformations in pregnant mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day. Betamethasone Dipropionate Betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.
Pediatric use
8.4 Pediatric Use The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in patients under 17 years of age is not recommended. Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base). In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see Warnings and Precautions (5.1) ] . Avoid use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the treatment of diaper dermatitis.
Geriatric use
8.5 Geriatric Use Clinical studies of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) under occlusion, such as in diaper dermatitis, is not recommended. Postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin .
Description
Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base) 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 molecular 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 molecular 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 USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetostearyl alcohol, ceteareth-30, propylene glycol, monobasic sodium phosphate monohydrate, and benzyl alcohol as a preservative. ChemicalStructure ChemicalStructure
Mechanism of action
12.1 Mechanism of Action Clotrimazole is an azole antifungal [see Clinical Pharmacology (12.4) ] . Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.
How supplied
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is supplied as follows: NDC 0168-0258-15, 15 gram tubes NDC 0168-0258-46, 45 gram tubes Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx only
Storage
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) is supplied as follows: NDC 0168-0258-15, 15 gram tubes NDC 0168-0258-46, 45 gram tubes Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx only
Patient information
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Inform the patient of the following: Pregnancy Advise pregnant women that clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1) ] . Lactation Advise a woman to use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ]. Important Administration Instructions Inform patients of the following:
• Use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base)as directed by the physician. It is for external use only.
• Avoid contact with the eyes, the mouth, or intravaginally.
• Advise patients to report any visual symptoms to their healthcare providers.
• Do not use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) on the face or underarms.
• Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) per week.
• When using clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks.
• Do not use clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) for any disorder other than that for which it was prescribed.
• Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
• Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
• This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46254616A R08/19 #52
Label text from the FDA structured product label by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC (revised Jul 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Clotrimazole in 20 products
- Betamethasone Dipropionate in 20 products
Clotrimazole and Betamethasone Dipropionate NDC products (20)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0741 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-3121 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-4876 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-6474 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | A-S Medication Solutions | ANDA |
| 0472-0379 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Actavis Pharma, Inc. | ANDA |
| 80425-0344 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 63629-8758 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 72189-182 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Direct Rx | ANDA |
| 0168-0258 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 68462-298 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Glenmark Pharmaceuticals Inc. USA | ANDA |
| 16714-496 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | NORTHSTAR RX LLC | ANDA |
| 68071-4134 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 68788-8419 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 63187-095 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Proficient Rx LP | ANDA |
| 71205-524 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Proficient Rx LP | ANDA |
| 67296-2272 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Redpharm Drug | ANDA |
| 70518-2352 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | REMEDYREPACK INC. | ANDA |
| 85766-196 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Sportpharm LLC | ANDA |
| 51672-1308 | Clotrimazole 10 mg/mL; Betamethasone Dipropionate .5 mg/mL Lotion | Sun Pharmaceutical Industries, Inc. | ANDA |
| 51672-4048 | Clotrimazole 10 mg/g; Betamethasone Dipropionate .5 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
Clotrimazole and Betamethasone Dipropionate recalls
- D-0727-2022 Apr 6, 2022 · Class III · Terminated
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample - D-1743-2019 Aug 21, 2019 · Class III · Terminated
Temperature Abuse: Complaints received of liquidy texture.
Frequently asked questions
What is Clotrimazole and Betamethasone Dipropionate used for?
Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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. Clotrimazole and betamethasone…
What are the side effects of Clotrimazole and Betamethasone Dipropionate?
Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) 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 Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial… See the full label for the complete list.
Who makes Clotrimazole and Betamethasone Dipropionate?
Clotrimazole and Betamethasone Dipropionate is listed by 15 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Advanced Rx Pharmacy of Tennessee, LLC, Bryant Ranch Prepack.
Has Clotrimazole and Betamethasone Dipropionate been recalled?
The FDA enforcement database lists 2 recalls for Clotrimazole and Betamethasone Dipropionate, most recently D-0727-2022 (class iii): Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample