Active Ingredient
CLOTRIMAZOLE USP, 1%
Clotrimazole Solution
FDA Label NDC 70795-8020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Graxcell Pharmaceutical, Llc. for the product Clotrimazole (NDC 70795-8020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTIFUNGAL
Uses
Cures most
- Athlete's foot (tinea pedis)
- Jock Itch (tinea cruris)
- Ringworm (tinea corporis)
- itching
- cracking
- burning
Effectively relieves
Discomfort which can accompany these conditions
Warnings
- For external use only
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
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 doctorif
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 Ingredients
polyethylene glycol 400
Questions?
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