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 (Topical Solution), 1%
- Manufacturer
- Puro Pharma Inc. | InvaDerm Corporation
- Effective date
- 2025-12-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:28:56
Label at a glance#
ProductClotrimazole (Topical Solution), 1%
Active ingredientCLOTRIMAZOLE
Label structure10 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...
Storage and handling
• store between 15°-30°C (59°-86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
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)
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 between 15°-30°C (59°-86°F)
Inactive ingredient
polyethylene glycol
Questions or comments?
Call 1-(845) 450-0141
Mon-Fri 9:00AM to 5:00PM EST
SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Lotrimin ® AF*
• Greaseless, Nonstaining
Not for Ophthalmic use.
Keep this and all medications out of the reach of children.
TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase.
*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin ®AF.
Keep this carton for important information.
Distributed by:
Puro Pharma Inc.
Poughkeepsie, NY 12601
Packaging
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0383474003341 | GTIN-13: 0383474003341 EAN-13: 0383474003341 GTIN-12: 383474003341 UPC-A: 383474003341 GTIN storage (14 digits): 00383474003341 | 8347400334-1.jpg |
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 |
|---|---|---|---|---|---|---|
| 83474-003-34 | Clotrimazole (Topical Solution), 1% | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | 2 | |
| 83474-003-34 | Clotrimazole (Topical Solution), 1% | 1 in 1 CARTON | SOLUTION | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83474-003-34 | ML - Milliliter | 83474-003 | fbc946b3-cb33-454d-8110-796ab938c1c9 | 1 | 2024-07-12 |
Products#
Every source-derived product name is available through these pages.
- Clotrimazole (Topical Solution), 1%
- Clotrimazole
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83474-003 | 83474-003-34 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| CLOTRIMAZOLE | G07GZ97H65 | ACTIB |
Source Document#
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 (Topical Solution), 1% | CLOTRIMAZOLE | Puro Pharma Inc. | cb424fa8-3ed5-45cd-b03f-64675584b34e | 2025-12-27 | Warnings | 83474-003-34 83474-003 83474000334 46f2ddcb-401f-9ed7-e063-6394a90a7a63 cb424fa8-3ed5-45cd-b03f-64675584b34e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.