Label: SALICYLIC ACID- callus removers patch
- NDC Code(s): 56104-244-01
- Packager: Premier Brands of America 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 January 25, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Active ingredient
- wash affected area and dry thoroughly
- if necessary, cut medicated patch to fit callus
- carefully adhere medicated patch directly over callus
- cover medicated patch with pad
- after 48 hours, remove medicated patch
- repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)
- may soak callus in warm water for 5 minutes to assist in removal
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
callus removers patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 40 mg in 4 Inactive Ingredients Ingredient Name Strength POLYVINYL ALCOHOL (UNII: 532B59J990) VINYL ACETATE (UNII: L9MK238N77) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-244-01 4 in 1 PACKAGE; Type 0: Not a Combination Product 06/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358F 06/16/2022 Labeler - Premier Brands of America Inc. (117557458)