Active Ingredient
Clotrimazole USP 1%
Clotrimazole Cream
FDA Label NDC 70000-0667
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110 Dba Leader for the product Clotrimazole (NDC 70000-0667). 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 this and all drugs out of the reach of children, do not use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal Cream
Uses
Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, burning, cracking, scaling and discomfort which accompany these conditions.
Warnings
For External use only.
Keep This And All Drugs Out Of The Reach Of Children
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 (1-800-222-1222) right away.
Do Not Use
Do not use on children under 2 years of age unless direcgted by a doctor
When Using This Product
When using this product avoid contact with eyes
Stop Use And Ask Doctor If
- irritaion occurs
- There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
Directions
- Wash the affected area and dry thoroughly.
● Apply a thin layer oover 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 the spaces between the 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 conditions persists longer, consult a doctor.
● This product is not effective on the scalp or nails.
Other Information
- store at controlled room temperature 15°-30°C (59°- 86°F)
- Close cap tightly after use.
Inactive Ingredients
Dimethyl Sulfoxide, Ethylparaben, Glycerol, Polyoxyethylene lauryl ether, Mineral Oil, Petrolatum, Water, alcohol, Mono and di-glycerides, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.
Questions?
Adverse drug event call 1-888-296-9067
Distributed by Cardinal Health
Dublin, Ohio 43017
www.myleader.com
1-800-200-6313
* This product is not manufactured or distributed by Schering-Plough, Inc., the distributor of Lotrimin®AF.
©2024 Cardinal Health. All rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.
CIN 5888649
* Please review the disclaimer below.
