Label: CLOTRIMAZOLE 1%- clotrimazole cream
- NDC Code(s): 63868-690-01
- Packager: Chain Drug Marketing Association Inc.
- 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.
Updated February 10, 2021
If you are a consumer or patient please visit this version.
- Active ingredient
- KEEP OUT OF REACH OF CHILDREN
- Stop Use and ask a Doctor if:
- Wash the affected area and dry thoroughly.
● Apply a thin layer of this 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 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.
- Inactive Ingredients
- Other Information
- Questions or Comments?
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-690 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHYL SULFOXIDE (UNII: YOW8V9698H) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) LAURETH-23 (UNII: N72LMW566G) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-690-01 1 in 1 BOX 08/13/2020 1 28.3 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 08/13/2020 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)