Clotrimazole Cream
Clotrimazole Cream is an FDA drug label for the active ingredient CLOTRIMAZOLE USP1% manufactured by Aldermed Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260608.
- Generic name
- CLOTRIMAZOLE USP1%
- Manufacturer
- Aldermed Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 87236-014
- Application
- M005
- Label effective
- 20260608
About this product
Clotrimazole Cream is an FDA-registered drug product whose active ingredient is CLOTRIMAZOLE USP1%. It is labelled by Aldermed Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87236-014, application M005, label effective 20260608. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing CLOTRIMAZOLE USP1% are most often described in connection with: jock itch, athlete foot, tinea pedis, cruris ringworm, corporis relieves, itching scaling, cracking burning, redness soreness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet
Dosage & Administration
Directions clean the affected area and dry thoroughly apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks for jock itch, use daily for 2 weeks if condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Warnings
Warnings For external use only Do not use on on children under 2 years of age unless directed by a doctor When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks when used for the treatment of jock itch there is no improvement within 4 weeks when used for athlete's foot or ringworm If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0211-2026 | Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55. | Blossom Pharmaceuticals | Class II | Ongoing | 20251210 |
| D-0210-2026 | Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01. | Blossom Pharmaceuticals | Class II | Ongoing | 20251210 |
| D-0156-2021 | RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1 | Taro Pharmaceuticals U.S.A., Inc. | Class II | Terminated | 20201223 |
| D-0150-2021 | CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03 | Taro Pharmaceuticals U.S.A., Inc. | Class II | Terminated | 20201223 |
| D-0155-2021 | Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01 | Taro Pharmaceuticals U.S.A., Inc. | Class II | Terminated | 20201223 |
Frequently asked questions
What is Clotrimazole Cream used for?
Uses for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet
Who makes Clotrimazole Cream?
Aldermed Inc. is the labeler of record for Clotrimazole Cream.
What form does Clotrimazole Cream come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Clotrimazole Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Clotrimazole Cream been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.