Label: SALICYLIC ACID- extra thick callus remover patch
- NDC Code(s): 63940-010-04
- Packager: Harmon Store 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 19, 2023
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- Active ingredient
For external use only.
Do noy use
- if you are diabetic
- if you have poor blood circulation
- on irritated skin or 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
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
extra thick callus remover patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-010 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:63940-010-04 4 in 1 PACKAGE; Type 0: Not a Combination Product 02/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358F 02/18/2014 Labeler - Harmon Store Inc. (804085293)