Label: CLOTRIMAZOLE solution
- NDC Code(s): 54633-018-30
- Packager: The Podiatree Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 26, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
• wash affected area and dry thoroughly
• apply to the affected area twice daily (morning and night) or as directed by your doctor
• supervise children in the use of this product
• for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• for athlete’s foot and ringworm infections, use daily for 4 weeks
• if condition persists longer, consult your doctor
- Inactive ingredient
- Other information
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Carton
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54633-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 1 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54633-018-30 1 in 1 CARTON 10/26/2018 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/26/2018 Labeler - The Podiatree Company (078656000)