Clotrimazole 10 mg/g Cream, 30 g
Other active recalls for Clotrimazole (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Read the full MedlinePlus article ↗- It depends on which product you have. The topical creams, solutions, and sprays treat common fungal skin infections — athlete's foot, jock itch, and ringworm. The CLOTIC ear drops...
- What kinds of infections does clotrimazole actually treat?
- You may start to notice some relief within a few days, but it's important to finish the full course. For athlete's foot and ringworm, that means using it every day for 4 weeks. For...
- How long do I need to use it before it starts working?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clotrimazole — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 461N1O614Y
A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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UNII 6O92ICV9RU
A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per g | Per 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 | $0.3577 | $10.73 / 30 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Clotrimazole Antifungal Cream 1 g/100g 00536-1265-26 | Rugby | 1 tube | $0.049 | — | Availability likely | — |
| Clotrimazole 1 g/100g 70000-0667-01 | Cardinal | 1 tube | $0.063 | — | Availability likely | — |
| Clotrimazole 1% Athletes Foot 10 mg/g 70677-1002-01 | STRATEGIC | 1 tube | $0.121 | — | Availability likely | — |
| TM-Clotrimazole 1 g/100g 83035-1062-03 | Singular | 1 tube | $0.121 | — | Availability likely | — |
| Leader Athletes Foot Clotrimazole .01 g/g 70000-0542-01 | LEADER | 1 tube | $0.122 | — | Discontinued | — |
| clotrimazole 1 g/100g 45802-0434-01 | Padagis | 1 tube | $0.146 | — | Discontinued | — |
| Clotrimazole 1 g/100g 51672-2002-01 | Sun | 1 tube | $0.185 | — | Availability likely | — |
| Good Neighbor Pharmacy Clotrimazole 10 mg/g 24385-0205-01 | AmerisourceBergen | 1 tube | $0.197 | — | Availability likely | — |
| Antifungal Cream 1 g/100g 68001-0475-45 | BluePoint | 1 tube | $0.197 | — | Availability likely | — |
| Clotrimazole 10 mg/g 51672-1275-01 | Sun | 1 tube | $0.198 | AB | Availability likely | — |
| Clotrimazole 10 mg/g 68462-0181-17 | Glenmark | 15 g | $0.198 | AB | Availability likely | — |
| Rugby Antifungal Clotrimazole .01 g/g 00536-1272-11 | Rugby | 1 tube | $0.228 | — | FDA listed | — |
| Clotrimazole 10 mg/g 00168-0133-15 | E. | 15 g | — | AB | FDA listed | — |
| Clotrimazole 10 mg/g 00363-2105-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Ringworm 10 mg/g 00363-2107-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Walgreens Jock Itch 10 mg/g 00363-2109-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Lotrimin 10 mg/g 11523-0963-01 | Bayer | 1 tube | — | — | FDA listed | — |
| Lotrimin Antifungal 10 mg/g 11523-1125-01 | Bayer | 1 tube | — | — | FDA listed | — |
| Lotrimin 10 mg/g 11523-6549-01 | Bayer | 1 tube | — | — | FDA listed | — |
| Dr Sheffield Athletes Foot 10 mg/g 11527-0071-15 | Sheffield | 1 tube | — | — | Discontinued | — |
| Jock Itch 10 mg/g 11673-0062-15 | TARGET | 1 tube | — | — | FDA listed | — |
| Target Jock Itch 10 mg/g 11673-0893-14 | Target | 1 tube | — | — | FDA listed | — |
| UpandUp Clotrimazole 10 mg/g 11673-0910-02 | Target | 1 tube | — | — | FDA listed | — |
| Rite Aid antifungal ringworm 1 g/100g 11822-1110-01 | Rite | 1 tube | — | — | FDA listed | — |
| Clotrimazole Jock Itch 10 mg/g 11822-3423-01 | Rite | 1 tube | — | — | FDA listed | — |
| Signature Care Jock Itch 10 mg/g 21130-0210-01 | Safeway | 1 tube | — | — | FDA listed | — |
| Signature Care Athletes Foot 10 mg/g 21130-0870-14 | Safeway | 1 tube | — | — | FDA listed | — |
| Antifungal 10 mg/g 21922-0094-04 | Encube | 1 tube | — | — | FDA listed | — |
| terrasil Folliculitis Cream Maximum Strength 1 g/100g 24909-0064-50 | Aidance | 50 g | — | — | FDA listed | — |
| Kroger ATHLETES FOOT 10 mg/g 30142-0305-01 | Kroger | 1 tube | — | — | FDA listed | — |
| Kroger Jock Itch 10 mg/g 30142-0510-01 | Kroger | 1 tube | — | — | FDA listed | — |
| TopCare Antifungal 10 mg/g 36800-0495-69 | Topco | 1 tube | — | — | FDA listed | — |
| HEB Antifungal 10 mg/g 37808-0305-01 | H | 1 tube | — | — | FDA listed | — |
| meijer Athletes Foot 10 mg/g 41250-0305-02 | Meijer | 1 tube | — | — | FDA listed | — |
| Publix athletic foot 10 mg/g 41415-0056-75 | Publix | 1 tube | — | — | FDA listed | — |
| CAREONE Clotrimazole 10 mg/g 41520-0305-02 | American | 1 tube | — | — | FDA listed | — |
| Jock-Eze 10 mg/g 47832-0071-14 | Bentlin | 1 tube | — | — | FDA listed | — |
| Clotrimazole Athletes Foot 10 mg/g 49035-0812-01 | Wal-Mart | 1 tube | — | — | FDA listed | — |
| Jock Itch Clotrimazole Antifungal .01 g/g 49035-0837-05 | WalMart | 1 tube | — | — | FDA listed | — |
| clotrimazole 1 g/100g 50090-0562-00 | A-S | 1 tube | — | — | FDA listed | — |
| clotrimazole 1 g/100g 50090-1770-00 | A-S | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 50090-4971-00 | A-S | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 50090-6546-00 | A-S | 1 tube | — | — | FDA listed | — |
| Clotrimazole 10 mg/g 50090-7343-00 | A-S | 30 g | — | AB | FDA listed | — |
| Live Better Antifungal 10 mg/g 51143-0002-01 | The | 1 tube | — | — | FDA listed | — |
| CAREALL Clotrimazole 10 g/g 51824-0063-01 | New | 28 g | — | — | FDA listed | — |
| CAREALL Clotrimazole 10 mg/g 51824-0093-01 | New | 28 g | — | — | FDA listed | — |
| Fungicure Night Cream 10 mg/g 52389-0681-02 | Kobayashi | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1% Athletes Foot 10 mg/g 52410-3024-04 | Shield | 28.3 g | — | — | FDA listed | — |
| Dermatin Antifungal .01 g/g 54473-0096-01 | Melaleuca, | 14 g | — | — | FDA listed | — |
| Fortinia 10 mg/g 54633-0314-80 | The | 80 g | — | — | FDA listed | — |
| Athletes Foot 10 mg/g 55315-0008-56 | FRED'S, | 1 tube | — | — | FDA listed | — |
| Family Wellness Clotrimazole 1 Anti Fungal Cream 10 mg/g 55319-0980-00 | Family | 1 tube | — | — | FDA listed | — |
| TheraPlus Plus 1 g/100g 55621-0003-01 | Zhejiang | 35 g | — | — | FDA listed | — |
| Cura Hongo Antifungal 1 g/100g 55758-0102-02 | Pharmadel | 1 tube | — | — | Discontinued | — |
| DG Health Athletes Foot 10 mg/g 55910-0118-00 | Dolgencorp, | 57 g | — | — | FDA listed | — |
| Publix Athletic Foot 10 mg/g 56062-0817-28 | PUBLIX | 1 tube | — | — | FDA listed | — |
| Micoclear 10 mg/g 57237-0350-15 | Rising | 1 tube | — | — | FDA listed | — |
| Mycozyl AC 10 mg/g 59088-0441-07 | PureTek | 85 g | — | — | FDA listed | — |
| Micotrin AC 10 mg/g 59088-0476-07 | PureTek | 85 g | — | — | FDA listed | — |
| Micomitin Antifungal 10 mg/g 59088-0642-07 | PureTek | 85 g | — | — | FDA listed | — |
| Clotrimazole 1% Athletes Foot 10 mg/g 59779-0305-01 | CVS | 1 tube | — | — | FDA listed | — |
| CVS Pharmacy ITCH RELIEF ANTIFUNGAL 10 mg/g 59779-0510-01 | CVS | 1 tube | — | — | FDA listed | — |
| CVS Antifungal Ringworm 1 g/100g 59779-0514-01 | CVS | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 63187-0501-15 | Proficient | 1 tube | — | — | FDA listed | — |
| clotrimazole 1 g/100g 63187-0559-15 | Proficient | 1 tube | — | — | FDA listed | — |
| Antifungal 1% Clotrimazole Cream 1 g/100mL 64412-2010-01 | Twincraft | 1 tube | — | — | FDA listed | — |
| Family Care Antifungal 10 mg/g 65923-0052-28 | United | 1 tube | — | — | FDA listed | — |
| Major Clotrimazole 10 mg/g 66267-0980-15 | NuCare | 14.17 g | — | — | FDA listed | — |
| WinCo Foods Antifungal 10 mg/g 67091-0196-28 | Winco | 1 tube | — | — | FDA listed | — |
| Clotrimazole 10 mg/gthis 67296-2252-03 | Redpharm | 30 g | — | AB | FDA listed | — |
| Dynarex Antifungal 1 g/100g 67777-0231-11 | Dynarex | 6 tubes | — | — | FDA listed | — |
| Antifungal 1 g/100g 67777-0727-02 | Dynarex | 72 tubes | — | — | FDA listed | — |
| clotrimazole 1 g/100g 68071-3395-03 | NuCare | 30 g | — | — | FDA listed | — |
| clotrimazole 1 g/100g 68071-4225-05 | NuCare | 15 g | — | — | FDA listed | — |
| Clotrimazole 1% 10 mg/g 68747-3024-04 | Dabur | 28.3 g | — | — | FDA listed | — |
| Rugby Antifungal Clotrimazole .01 g/g 68788-8091-02 | Preferred | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 68788-8216-03 | Preferred | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 68788-8830-02 | Preferred | 1 tube | — | — | FDA listed | — |
| Rugby Clotrimazole Antifungal Cream 1 g/100g 68788-8901-02 | Preferred | 1 tube | — | — | FDA listed | — |
| PerfectHeal Antifungal 1 g/100g 69070-0303-01 | Zhejiang | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 69396-0001-04 | TRIFECTA | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 69396-0038-05 | Trifecta | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1 g/100g 69396-0087-01 | TRIFECTA | 1 tube | — | — | FDA listed | — |
| FifthPulse clotrimazole cream 4oz 1 g/100g 69571-0019-01 | Front | 113.4 g | — | — | FDA listed | — |
| Clotrimazole 1% Athletes Foot 10 mg/g 69771-0032-23 | GERI-GENTLE | 113 g | — | — | FDA listed | — |
| Antifungal 1% Clotrimazole Cream 1 g/100mL 70856-3585-01 | Defense | 1 tube | — | — | FDA listed | — |
| Clotrimazole 10 mg/g 71205-0432-15 | Proficient | 1 tube | — | AB | FDA listed | — |
| Clotrimazole 1 g/100g 71205-0434-05 | Proficient | 1 tube | — | — | FDA listed | — |
| Rugby Antifungal Clotrimazole .01 g/g 71205-0738-15 | Proficient | 1 tube | — | — | FDA listed | — |
| Trimazole 1 g/100g 73352-0570-01 | Trifluent | 1 tube | — | — | FDA listed | — |
| Clotrimazole 1% Topical Antifungal Cream 1 g/100g 73715-0004-01 | Mohnark | 28 g | — | — | Discontinued | — |
| Clotrimazole 10 mg/g 80489-0002-01 | OL | 1 tube | — | — | FDA listed | — |
| Thera plus Antifungal Clotrimazole 10 mg/g 80684-0039-01 | FOURSTAR | 1 tube | — | — | FDA listed | — |
| Up and Up Athletes Foot 10 mg/g 82442-0022-28 | Target | 1 tube | — | — | FDA listed | — |
| SIMPLY VITAL Antifungal Cream 10 mg/mL 82460-0344-00 | ALPHA | 60 ml | — | — | FDA listed | — |
| SimplyVital Antifungal Clotrimazole 10 mg/mL 82460-0990-00 | Alpha | 1 jar | — | — | FDA listed | — |
| Clotrimazole 1% 1 g/100g 83324-0041-01 | Chain | 1 tube | — | — | FDA listed | — |
| PHARMBANNER Antifungal Soothing Cream 1 g/100g 83818-0017-01 | Shenzhen | 60 g | — | — | FDA listed | — |
| Megababe Fun Gal Stuff Antifungal 10 mg/g 84000-0908-00 | Megababe | 1 tube | — | — | FDA listed | — |
| Clotrimazole 10 mg/g 84387-0004-01 | ALLIED | 28.4 g | — | — | FDA listed | — |
| ElixirCurozole 1 g/100g 84546-0003-01 | ELIXIR | 1 tube | — | — | FDA listed | — |
| seebeellar clotrimazole 1% antifungal cream 1 g/100g 84558-0014-01 | GUANGZHOU | 100 g | — | — | FDA listed | — |
| Velloryn 1% Clotrimazole ANTIFUNGAL 1 g/100mL 84558-0017-01 | GUANGZHOU | 100 ml | — | — | FDA listed | — |
| Antifungal 1 g/100g 84722-3059-00 | VIVE | 1 g | — | — | FDA listed | — |
| DERMFREE Clotrimazole 1 g/100g 85248-0036-01 | Jiangxi | 60 g | — | — | FDA listed | — |
| SERYNTH Clotrimazole 1 g/100g 85248-0101-01 | Jiangxi | 30 g | — | — | FDA listed | — |
| Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGAL 1 g/100g 85248-0143-01 | Jiangxi | 100 g | — | — | FDA listed | — |
| BODYKOO JOCK ITCH Cream 1 g/100g 85248-0228-01 | Jiangxi | 30 g | — | — | FDA listed | — |
| Tagrid Antifungal Ringworm Treatment 1% CLOTRIMAZOLE 1 g/100g 85384-0006-01 | TAGRID | 100 g | — | — | FDA listed | — |
| Tagrid Balanitis Relief 1 g/100g 85384-0018-01 | TAGRID | 30 g | — | — | FDA listed | — |
| Tagrid Antifungal Clotrimazole 1% 1 g/100g 85384-0019-01 | TAGRID | 100 g | — | — | FDA listed | — |
| Tagrid Antifungal Jock Itch Cream Non-Steroidal Clotrimazole 1% 1 g/100g 85384-0021-01 | TAGRID | 60 g | — | — | FDA listed | — |
| Tagrid Intertrigo Cream For Skin Fold Rash Clotrimazole 1% 1 g/100g 85384-0022-01 | TAGRID | 56.7 g | — | — | FDA listed | — |
| Tinea Versicolor Treatment Cream 10 mg/g 85398-0002-01 | Beautivity | 60 g | — | — | FDA listed | — |
| Hermon Clotrimazole antifungal treatment cream .57 g/57g 85398-0010-01 | Beautivity | 57 g | — | — | FDA listed | — |
| Terthon Clotrimazole 1% Antifungal Cream 1 g/100g 85849-0010-01 | SOLALIA | 30 g | — | — | FDA listed | — |
| Kerova ANTIFUNGAL 1 g/100g 85959-0002-01 | Guangzhou | 100 g | — | — | FDA listed | — |
| Kerova Clotrimazole 1 g/100g 85959-0003-01 | Guangzhou | 100 g | — | — | FDA listed | — |
| Clotrimazole 1% 10 mg/g 87228-1010-01 | PHARMACY | 28.4 g | — | — | FDA listed | — |
| Clotrimazole Cream 1 g/100g 87236-0014-14 | Aldermed | 1 tube | — | — | FDA listed | — |
| Athletes Foot Cream 1 g/100g 87739-0001-01 | Shenzhen | 28 g | — | — | FDA listed | — |
| Fungicure Liquid Gel 10 mg/g 52389-0733-09 | Kobayashi | 1 tube | — | — | FDA listed | — |
| Tagrid Antifungal Treament Clotrimazole 1% 10 mg/g 85384-0012-01 | TAGRID | 20 g | — | — | FDA listed | — |
| FifthPulse Clotrimazole Antifungal 10 mg/g 87525-0002-01 | WeCare | 1 tube | — | — | FDA listed | — |
| Tinea Versicolor Treatment Bar 10 mg/g 85398-0003-01 | Beautivity | 116 g | — | — | FDA listed | — |
| Alevazol 10 mg/g 29978-0918-60 | Capital | 1 tube | — | — | FDA listed | — |
| CAREALL Clotrimazole 10 mg/g 51824-0121-01 | New | 28 g | — | — | FDA listed | — |
| Clotrimazole 10 mg/g 73581-0451-01 | YYBA | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67296-2252-03 You're viewing this | 30 g in 1 TUBE (67296-2252-3) | 2010-08-04 | Active |
🧭 About this NDC listing & data coverage
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 | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gently massage sufficient clotrimazole cream into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritis, usually occurs within the first week of treatment with clotrimazole cream. If the patient shows no clinical improvement after four weeks of treatment with clotrimazole cream, the diagnosis should be reviewed.
⛔ Contraindications ▾
CONTRAINDICATIONS Clotrimazole cream is contraindicated in individuals sensitive to its components.
⚠️ Warnings ▾
WARNINGS Clotrimazole cream is not for ophthalmic use.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritis, urticaria, burning, and general irritation of the skin.
🔄 Drug Interactions ▾
Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
🤰 Pregnancy ▾
Usage in Pregnancy: Pregnancy Category B The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. (See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects.
There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole. High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embroyotoxicity (possible secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning.
However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.
🆘 Overdosage ▾
OVERDOSAGE Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur . The primary action of clotrimazole is against dividing and growing organisms. In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton floccosum, Microsporum canis and Candida species including Candida albicans .
In general, the in vitro activity of clotrimazole corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes ( Trichophyton, Microsporum, and Epidermophyton ), and to that of the polyenes (amphotericin B and nystatin) against budding fungi ( Candida ). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system, clotrimazole and micronazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans . Strains of fungi having a natural resistance to clotrimazole are rare.
Only a single isolate of Candida guilliermondi has been reported to have primary resistance to clotrimazole. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans and Trichophyton mentagrophytes . No appreciable change in sensitivity was detected after successive passage of isolates of C. albicans, C. krusei , or C. pseudotropicalis in liquid or solid media containing clotrimazole.
Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of C. albicans . Slight, reversible resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report that records the clinical emergence of C. albicans strain with considerable resistance to flucytosine and micronazole, and with cross-resistance to clotrimazole, the strain remained sensitive to nystatin and amphotericin B.
In studies of the mechanism of action, the minimum fungicide concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug. Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites.
Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 in the stratum corneum to 0.5 to 1 mcg/cm 3 in the stratum reticulare, and 0.1 mcg/cm 3 in the subcutis. No measurable amount of radioactivity (≤0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream.
Only 0.5% or less of the applied radioactivity was excreted in the urine. Following intravaginal administration of 100 mg 14 C-clotrimazole vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 μg equivalent/mL of clotrimazole, was reached one to two days after application. After intravaginal administration of 5 g of 1% 14 C-clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 μg equivalents/mL were reached between 8 and 24 hours after application.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clotrimazole cream USP, 1% is supplied in 15, 30, 45 and (2 x 45) gram tubes. NDC 68462-181-17 (15 g) NDC 68462-181-35 (30 g) NDC 68462-181-47 (45 g) NDC 68462-181-48 (2 x 45 g)
📦 Storage and Handling ▾
Store between 2°C- 30°C (36°F -86°F).
📋 Description ▾
DESCRIPTION Clotrimazole cream USP, 1% contains clotrimazole USP, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22 H 17 ClN 2 ; a molecular weight of 344.84; and the structural formula: Clotrimazole USP is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative. structure
💬 Information for Patients ▾
Information for Patients: The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after four weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
Avoid the use of occlusive wrappings or dressings. Avoid sources of infection or reinfection.