Active Ingredient
Clotrimazole 1%
Clotrimazole Cream 1%
FDA Label NDC 70512-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sola Pharmaceuticals for the product Clotrimazole Cream 1% (NDC 70512-100). 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, usage, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Usage
- For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis).
- Relieves itching, cracking scaling irritation and chafing associated with these conditions.
Warnings
Do not use on children under 2 years of age unless directed by a doctor.
For external use only.
Avoid contact with eyes.
If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.
Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs our of the reach of children. In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center right away.
Directions
- Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor.
- Supervise children in the use of this product.
- For athlete's foot pay special attention to the spaces between toes. Wear well fitting ventilated shoes and change shoes and socks at least once daily.
- For athlete's foot and ringworm use daily for 4 weeks.
- For jock itch use daily for 2 weeks.
- If condition persist longer consult a doctor.
- This product is not effective on scalp or nails.
Inactive Ingredients
Cetomacragol 1000, Cetostearyl alcohol, Liquid paraffin, Methyl Paraben, Propyl paraben, Propylene glycol, Purified water, White soft paraffin.
Other Information
- Store between 20°C and 25°C (68°F and 77°F)
Questions or comments?
Call 1-866-747-7365
Package Display Panel
Questions or comments?
Call 1-866-747-7365
Manufactured for : SOLA Pharmaceuticals
Baton Rouge, LA 70810
Store in a dry, cool place
For Comments or Questions, call 866-747-7365
Clotrimazole 1% Cream
NDC 70512-100-30
Qty: 28.4g
* Please review the disclaimer below.
