Indications and uses
Cures most Athlete's foot (tinea pedis) Jock Itch (tinea cruris) Ringworm (tinea corporis) Effectively relieves Itching Cracking Burning Discomfort which can accompany these conditions
Clotrimazole Solution
- Manufacturer
- Marlex Pharmaceuticals Inc
- Effective date
- 2025-10-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:24
Label at a glance#
ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure11 sections
Dosage and administration
This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the u...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
CLOTRIMAZOLE -clotrimazolesolutionMarlexPharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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ClotrimazoleTopical Solution USP,1%
Drug Facts
Active ingredient
Clotrimazole USP, 1%
Purpose
Antifungal
Uses
Cures most
- Athlete's foot (tinea pedis)
- Jock Itch (tinea cruris)
- Ringworm (tinea corporis)
Effectively relieves
- Itching
- Cracking
- Burning
Discomfort which can accompany these conditions
Warnings
For external use only
Ask a doctor before use
on children under 2 years of age
When using this product
avoid contact with eyes
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- clean the affected area and dry thoroughly
- apply a thin layer of the product 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; change shoes and socks at least once daily
Other information
- Store at 15° to 30°C (59° to 86°F)
Inactive ingredient
polyethylene glycol
INFORMATION FOR OWNERS/CAREGIVERS SECTION
keep this carton for important information.
Manufactured for and Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
ϯ All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin®AF.
Rev. 11/18 IT
PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
Rev. 11/18 IT
NDC 10135-0671-81
Clotrimazole
Topical Solution
USP, 1 %
10 mL
PRINCIPAL DISPLAY PANEL
Rev. 01/20 IT
NDC 10135-0671-91
Clotrimazole
Topical Solution
USP, 1 %
30 mL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-671-81 | Clotrimazole | 10 mL in 1 BOTTLE | SOLUTION | 10 | 8 | |
| 10135-671-81 | Clotrimazole | 1 in 1 CARTON | SOLUTION | 1 | 8 | |
| 10135-671-91 | Clotrimazole | 1 in 1 CARTON | SOLUTION | 1 | 8 | |
| 10135-671-91 | Clotrimazole | 30 mL in 1 BOTTLE | SOLUTION | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-671-81 | ML - Milliliter | 10135-671 | 20b9cd43-b3b8-45ab-b185-aa435e24717a | 1 | 2019-01-24 |
| 10135-671-91 | ML - Milliliter | 10135-671 | c004140e-3550-406d-8686-1fc7bb50526d | 1 | 2020-04-20 |
Products#
Every source-derived product name is available through these pages.
- Clotrimazole
- POLYETHYLENE GLYCOL 400
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10135-671 | 10135-671-81, 10135-671-91 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CLOTRIMAZOLE | G07GZ97H65 | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2024-07-18 | full-release | 2026-06-01 00:15:36 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clotrimazole | CLOTRIMAZOLE | Marlex Pharmaceuticals Inc | d6e95c99-e055-436a-8ee6-40d6e199eaca | 2025-10-08 | Warnings | 10135-671-81 10135-671-91 10135-671 10135067181 10135067191 40a87948-bcf6-0552-e063-6394a90a2d0d d6e95c99-e055-436a-8ee6-40d6e199eaca |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.