Active Ingredient
Clotrimazole USP, 1%
Clotrimazole Solution
FDA Label NDC 69848-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Granules Usa, Inc. for the product Clotrimazole (NDC 69848-001). 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, warning, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of the reach of children., 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), and
- Ringworm (tinea corporis).
Effective relieves
• itching
• cracking
• burning
• discomfort which can accompany these conditions
Warning
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 The 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 400.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
Clotrimazole 1% Topical Solution
10 mL (300000264 R 00 Final)
* Please review the disclaimer below.
