Clotrimazole (topical Solution), 1% Solution
FDA Label NDC 83474-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puro Pharma Inc. for the product Clotrimazole (topical Solution), 1% (NDC 83474-003). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Packaging
Clotrimazole-003 (8347400334 1)
* Please review the disclaimer below.
