Label: ANTIFUNGAL- clotrimazole cream
- NDC Code(s): 21922-094-04, 21922-094-05
- Packager: Encube Ethicals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 4, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
-
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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21922-094 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) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CETYL ESTERS WAX (UNII: D072FFP9GU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21922-094-04 1 in 1 CARTON 03/06/2025 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:21922-094-05 1 in 1 CARTON 03/06/2025 2 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 Drug M005 03/06/2025 Labeler - Encube Ethicals, Inc. (116982244) Registrant - Encube Ethicals Private Limited (915834105) Establishment Name Address ID/FEI Business Operations Encube Ethicals Private Limited 725076298 analysis(21922-094) , label(21922-094) , manufacture(21922-094) , pack(21922-094)
