Label: CLOTRIMAZOLE (TOPICAL SOLUTION), 1%- clotrimazole solution
- NDC Code(s): 83474-003-34
- Packager: Puro Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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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
- Inactive ingredient
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Lotrimin® AF*
• Greaseless, Nonstaining
Not for Ophthalmic use.
Keep this and all medications out of the reach of children.
TAMPER EVIDENT: This bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at the time of purchase.
*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Lotrimin® AF.
Keep this carton for important information.
Distributed by:
Puro Pharma Inc.
Poughkeepsie, NY 12601 - Packaging
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE (TOPICAL SOLUTION), 1%
clotrimazole solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83474-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83474-003-34 1 in 1 CARTON 04/15/2024 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 04/15/2024 Labeler - Puro Pharma Inc. (128518845)
