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Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream, 15 g — NDC 72189-182-15 (Billing 72189-0182-15)

by Direct Rx · 15 g in 1 TUBE

This is a package of 15 g of Clotrimazole and Betamethasone Dipropionate 10 mg/g; .5 mg/g Cream from Direct Rx, marketed since Feb 2021 and currently FDA-listed. It is this product's only package size.

NDC 72189-0182-15
🏷️ FDA NDC (as labeled) 72189-182-15 billing pads the product 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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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-182-15
Product NDC 72189-182
11-digit billing NDC 72189018215
NCPDP billing unit GM — per gram (weight)
RxCUI 308714
UNII G07GZ97H65, 826Y60901U
Application # ANDA202894
SPL Set ID bbf26437-c9b4-d8e6-e053-2a95a90a0062
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 2021-02-23
Route TOPICAL
Dosage form CREAM
Substance CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE

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

GPI-14 90159902053710
GPI class Clotrimazole-Betamethasone
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
  • GPI-14 (Medi-Span): 90159902053710
  • HICL (First Databank): 003197
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 308714
Why two NDCs? The FDA registers this code as 72189-182-15 — a 5-3-2 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 product segment → 72189-0182-15. 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
72189-0182-15 You're viewing this Main listing 15 g in 1 TUBE 2021-02-23 — 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/g 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/gthis 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

🏛️
2021
On the market since
Feb 2021
📍
2026
Currently FDA-listed
5 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

LabelerDirect Rx
Application holderGLENMARK SPECIALTY SA
FDA applicationANDA202894 (ANDA)
Labeler code72189
First marketedFeb 2021
Product typeHuman Prescription Drug
Portfolio204 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

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.

⏱️ Dosage and Administration 180 words ▾

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.

💊 Dosage Forms and Strengths 42 words ▾

Cream, 1%/0.05%. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole, USP and 0.643 mg of betamethasone dipropionate, USP (equivalent to 0.5 mg of betamethasone) in a white to off-white, uniform and smooth cream base.

⛔ Contraindications 1 words ▾

None.

⚠️ Warnings and Cautions ~2 min read ▾

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 207 words ▾

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 ▾

8.1Pregnancy Risk Summary There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify 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 betamethasone dipropionate cream or fr… [Excerpted — this section continues on DailyMed.]

🧬 Clinical Pharmacology ~2 min read ▾

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.

📦 How Supplied / Storage and Handling 51 words ▾

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% is white to off-white, uniform and smooth cream and supplied in Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not keep in cold or hot weather conditions. Rx only

📋 Description 187 words ▾

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base), contains combinations of clotrimazole, USP, an azole antifungal, and betamethasone dipropionate, USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-[(2-Chlorophenyl)diphenylmethyl]-1H-imidazole, with the empirical formula C22H17ClN2, a molecular weight of 344.84 g/mol, and the following structural formula: [Clotrimazolestructure] Clotrimazole, USP is a white to pale yellow, crystalline powder, odorless, practically insoluble in water, freely soluble in methanol, in acetone, in chloroform and in alcohol.

Betamethasone dipropionate, USP has the chemical name 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.60 g/mol, and the following structural formula: [betamethasonestructure] Betamethasone dipropionate, USP is a white to almost white crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in alcohol. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg clotrimazole, USP and 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white, uniform and smooth cream consisting of benzyl alcohol, ceteareth-30, cetyl alcohol, mineral oil, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium hydroxide, stearyl alcohol, and white petrolatum.

💬 Patient Medication Information ~3 min read ▾

Clotrimazole (kloe trim' a zole) and Betamethasone Dipropionate (bay" ta meth' a sone dye proe' pee oh nate) Cream USP, 1%/0.05% Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina. What is clotrimazole and betamethasone dipropionate cream? • Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older.

Clotrimazole and betamethasone dipropionate cream is used for fungal infections that are inflamed and have symptoms of redness or itching. • Clotrimazole and betamethasone dipropionate cream should not be used in children under 17 years of age. Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if clotrimazole and betamethasone dipropionate cream will harm your unborn baby.

If you use clotrimazole and betamethasone dipropionate cream during pregnancy, use clotrimazole and betamethasone dipropionate cream on the smallest area of the skin and for the shortest time needed. • are breastfeeding or plan to breastfeed. It is not known if clotrimazole and betamethasone dipropionate cream passes into your breast milk. Breastfeeding women should use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest time needed while breastfeeding.

Do not apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid contact with your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

How should I use clotrimazole and betamethasone dipropionate cream? • Use clotrimazole and betamethasone dipropionate cream exactly as your healthcare provider tells you to use it. • Use clotrimazole and betamethasone dipropionate cream for the prescribed treatment time, even if your symptoms get better. • Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream in 1 week. • Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use clotrimazole and betamethasone dipropionate cream in the groin area. • Do not use clotrimazole and betamethasone dipropionate cream on your face or underarms (armpits). • For treatment of fungal infections of the groin and body: • Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 1 week. • Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment. • Do not use clotrimazole and betamethasone dipropionate cream for longer than 2 weeks. • For treatment of fungal infections of the feet: • Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 2 weeks. • Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment.

Do not use clotrimazole and betamethasone dipropionate cream longer than 4 weeks. • Wash your hands after applying clotrimazole and betamethasone dipropionate cream. What should I avoid while using clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream should not be used to treat diaper rash or redness.

You should avoid applying clotrimazole and betamethasone dipropionate cream in the diaper area. What are the possible side effects of clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipro… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies 115 words ▾

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 179 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 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.

📄 Package Label / Principal Display Panel 1 words ▾

18215

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

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Is this package still being marketed?
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Who lists this product with the FDA?
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Do I need a prescription for this product?
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Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72189-0180-07 · Direct 72189-0184-14 · direct →
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