Country: United States
Language: English
Source: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
AmerisourceBergen Drug Corporation
TOPICAL
OTC DRUG
Callus remover - for the removal of calluses - relieves pain by removing calluses
OTC monograph final
SALICYLIC ACID- MEDICATED CALLUS REMOVERS PATCH AMERISOURCEBERGEN DRUG CORPORATION ---------- GNP MEDICATED CALLUS REMOVERS _ACTIVE INGREDIENT_ Salicylic acid 40% _PURPOSE_ Callus remover _USES_ for the removal of calluses relieves pain by removing calluses _WARNINGS_ 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 STOP USE AND ASK A DOCTOR IF discomfort persists KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ 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_ store between 15°C to 30°C (59°F to 86°F) _INACTIVE INGREDIENTS_ acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol _QUESTIONS?_ call 1-888-423-0139 PRINCIPAL DISPLAY PANEL GOOD NEIGHBOR PHARMACY CALLUS REMOVERS SALICYLIC ACID Callus removal treatment Protect against pressure and pain 4 MEDICATED PATCHES/6 PADS SALICYLIC ACID medicated callus removers patch PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:46122-524 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 AmerisourceBergen Drug Corporation 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:46122-524- 13 4 in 1 PACKAGE; Type 0: Not a Combination Product 12/21/2017 MARKETING INFORMATION MARKETING Read the complete document