Label: CLOTRIMAZOLE solution
- NDC Code(s): 71399-0500-1
- Packager: Akron Pharma Inc
- Category: HUMAN OTC DRUG LABEL
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 November 20, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
- 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 ingredient
- PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-0500 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:71399-0500-1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333C 05/15/2017 Labeler - Akron Pharma Inc (067878881) Registrant - Akron Pharma Inc (067878881) Establishment Name Address ID/FEI Business Operations SLV PHARMACEUTICALS LLC 081225162 manufacture(71399-0500)