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Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream — NDC 50090-4876-0 (Billing 50090-4876-00)

by A-S Medication Solutions · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream from A-S Medication Solutions, marketed since May 2001 and currently FDA-listed. It is this product's only package size.

NDC 50090-4876-00
🏷️ FDA NDC (as labeled) 50090-4876-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-4876-0
Product NDC 50090-4876
11-digit billing NDC 50090487600
NCPDP billing unit GM — per gram (weight)
RxCUI 308714
UNII G07GZ97H65, 826Y60901U
Application # ANDA075673
SPL Set ID 2eff5585-f013-42f0-b678-bb5406e8188c
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-05-29
Route TOPICAL
Dosage form CREAM
Substance CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 036534
GCN 06919
HICL code 003197
Ingredient (HICL) Clotrimazole/Betamethasone Dip
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5M
Therapeutic class — specific (HIC3) Topical Antifungal/Anti-Inflammatory,Steroid Agent
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name CLOTRIMAZOLE-BETAMETHASONE CRM
FDB brand name Clotrimazole-Betamethasone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 036534
  • GCN: 06919
  • HICL (First Databank): 003197
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 308714
Why two NDCs? The FDA registers this code as 50090-4876-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 50090-4876-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLOTRIMAZOLE-BETAMETHASONE CRM Ingredient Clotrimazole/Betamethasone Dip

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3646 $5.47 / 15 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-4876-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE 2020-02-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 00168-0258-15 E. 15 g $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 00472-0379-15 Actavis 1 tube $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 16714-0496-01 NORTHSTAR 1 tube $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 51672-4048-01 Sun 1 tube $0.201 AB Availability likely —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 68462-0298-17 Glenmark 15 g $0.226 — FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-0741-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-3121-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/gthis 50090-4876-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 50090-6474-00 A-S 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 63187-0095-15 Proficient 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 63629-8758-01 Bryant 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 68071-4134-04 NuCare 45 g — — FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 68788-8419-01 Preferred 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 70518-2352-00 REMEDYREPACK 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 71205-0524-15 Proficient 15 g — — FDA listed —
Clotrimazole And Betamethasone Dipropionate 10 mg/g; .5 mg/g 72189-0182-15 Direct 15 g — — FDA listed —
Clotrimazole/Betameth .5 mg/g; 10 mg/g 72189-0518-15 Direct_Rx 15 g — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 80425-0344-01 Advanced 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 85766-0196-15 Sportpharm 1 tube — AB FDA listed —
Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g 67296-2272-01 Redpharm 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2001
On the market since
May 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA075673 (ANDA)
Labeler code50090
First marketedMay 2001
Product typeHuman Prescription Drug
Portfolio2,811 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 107 words ▾

1 INDICATIONS AND USAGE 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. Clotrimazole and Betamethasone Dipropionate Cream 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 ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 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. 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 71 words ▾

3 DOSAGE FORMS AND STRENGTHS 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. Cream, 1%/0.05% ( 3 ) 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). ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS 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 )

5.1Effects on Endocrine System Clotrimazole and betamethasone dipropionate cream 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 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 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) ] .

5.2Diaper Dermatitis The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended.

5.3Ophthalmic 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 with eyes.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS 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 Northstar RxLLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 1% included rash, edema, and secondary infection.

6.2Postmarketing 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 ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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 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 may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream 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.

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.

8.2Lactation 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 and any potential adverse effects on the breastfed infant from clotrimazole and be… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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 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 may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream 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.

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 ~1 min read ▾

8.4Pediatric Use The use of clotrimazole and betamethasone dipropionate cream 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. In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (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 trial, 8 of 17 (47.1%) evaluable pediatric subjects (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. 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 in the treatment of diaper dermatitis.

🧓 Geriatric Use 102 words ▾

8.5Geriatric Use Clinical studies of clotrimazole and betamethasone dipropionate cream 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 under occlusion, such as in diaper dermatitis, is not recommended.

Postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream 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.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics Vasoconstrictor Assay : Studies performed with clotrimazole and betamethasone dipropionate cream indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high-potency topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3Pharmacokinetics Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of clotrimazole and betamethasone dipropionate cream has not been studied. 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. 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 (2) ] . 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.

12.4Microbiology Mechanism of Action : Clotrimazole, an azole antifungal agent, inhibits 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 Vitro and In Vivo : Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections, Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum [see Indications and Usage (1) ] . 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 .

🧬 Mechanism of Action 52 words ▾

12.1Mechanism 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 / Storage and Handling 19 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-4876 NDC: 50090-4876-0 15 g in a TUBE / 1 in a CARTON

📋 Description 158 words ▾

11 DESCRIPTION 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. Chemical Structure Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING 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 may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream 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 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 directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ]. Important Administration Instructions Inform the patient of the following: Use clotrimazole and betamethasone dipropionate cream 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 on the face or underarms.

Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream per week. When using clotrimazole and betamethasone dipropionate cream 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 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 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.

🧬 Pharmacokinetics 147 words ▾

12.3Pharmacokinetics Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of clotrimazole and betamethasone dipropionate cream has not been studied. 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. 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 (2) ] . 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.

🧬 Pharmacodynamics 43 words ▾

12.2Pharmacodynamics Vasoconstrictor Assay : Studies performed with clotrimazole and betamethasone dipropionate cream indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high-potency topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

🔬 Clinical Studies 118 words ▾

14 CLINICAL STUDIES 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.

🧪 Nonclinical Toxicology 184 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of the combination of clotrimazole and betamethasone dipropionate or either component individually. 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.

In a combined study of the effects of clotrimazole on fertility, embryofetal development, and postnatal development, male and female rats were dosed orally (diet admixture) with dose levels of 5, 10, 25, or 50 mg/kg/day 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. Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 181 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of the combination of clotrimazole and betamethasone dipropionate or either component individually. 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.

In a combined study of the effects of clotrimazole on fertility, embryofetal development, and postnatal development, male and female rats were dosed orally (diet admixture) with dose levels of 5, 10, 25, or 50 mg/kg/day 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. Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.

📄 Patient Package Insert ~3 min read ▾

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% This Patient Information has been approved by the U.S. Food and Drug Administration. 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… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 6 words ▾

Clotrimazole and Betamethasone Dipropionate Label Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
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A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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← 50090-4875-00 · A-S 50090-4881-00 · A-S →
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