Label: SALICYLIC ACID- callus removers patch
- NDC Code(s): 56104-013-04
- Packager: Premier Brands of America 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.
Drug Label Information
Updated January 26, 2023
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- Official Label (Printer Friendly)
- Active ingredient
For external use only.
Do not use
- if you are a diabetic
- have poor blood circulation
- on irritated skin, on any area that is infected or reddened
- wash affected area and dry thoroughly
if necessary, cut medicated patch to fit callus
apply adhesive side down of medicated patch onto 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
- continued wearing of pad (without patch) will help prevent recurrence of calluses
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
callus removers patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-013 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:56104-013-04 4 in 1 PACKAGE; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358F 01/01/2013 Labeler - Premier Brands of America Inc. (117557458)