Label: CLOTRIMAZOLE cream
- NDC Code(s): 68016-035-06
- Packager: Chain Drug Consortium, LLC
- 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 November 21, 2022
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- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- wash 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, 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 lasts longer, contact a doctor
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-035 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 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-035-06 1 in 1 CARTON 09/11/2003 1 28 g in 1 TUBE; 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 09/11/2003 Labeler - Chain Drug Consortium, LLC (101668460)