Label: CORNSTICK- salicylic acid stick
- NDC Code(s): 10107-240-01, 10107-240-02
- Packager: Balassa Laboratories 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 10, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
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Directions
- wash affected area and dry thoroughly
- keeping the product off the surrounding skin, apply thin layer of product to the corn or callus
- cover affected area with a clean bandage
- repeat this procedure every 48 hours as needed for up to 14 days (until the corn or callus is removed)
- may soak corn in warm water for 5 minutes to assist in removal
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 5.1 g Tube in Carton
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INGREDIENTS AND APPEARANCE
CORNSTICK
salicylic acid stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10107-240 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID .4 g in 1 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) MENTHOL (UNII: L7T10EIP3A) YELLOW WAX (UNII: 2ZA36H0S2V) PARAFFIN (UNII: I9O0E3H2ZE) ROSIN (UNII: 88S87KL877) D&C GREEN NO. 6 (UNII: 4QP5U84YF7) D&C VIOLET NO. 2 (UNII: 350KA7O6HK) D&C YELLOW NO. 11 (UNII: 44F3HYL954) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10107-240-02 1 in 1 CARTON 06/15/2017 1 NDC:10107-240-01 5.1 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358F 07/01/1967 Labeler - Balassa Laboratories Inc. (069162485) Establishment Name Address ID/FEI Business Operations Balassa Laboratories Inc. 069162485 manufacture(10107-240) , label(10107-240) , pack(10107-240)