Label: CLOTRIMAZOLE solution
- NDC Code(s): 70795-8020-1
- Packager: GRAXCELL PHARMACEUTICAL, 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.
Updated December 21, 2021
If you are a consumer or patient please visit this version.
- DRUG FACTS
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
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 ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70795-8020 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:70795-8020-1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/08/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 12/08/2017 Labeler - GRAXCELL PHARMACEUTICAL, LLC. (056556923) Establishment Name Address ID/FEI Business Operations GRAXCELL PHARMACEUTICAL, LLC. 056556923 manufacture(70795-8020)