Label: SALICYLIC ACID- medicated callus removers extra thick patch

  • 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.

Drug Label Information

Updated December 12, 2019

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  • ​Active ingredient

    Salicylic acid 40%

  • Purpose

    Callus remover

  • Use

    • for the removal of calluses
    • relieves pain by removing calluses
  • Warnings

    For external use only.

    Do not use

    • if you are a diabetic
    • if you 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 area 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 corn is removed)
    • may soak corn 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 1-866-964-0939

  • Principal Display Panel

    Premier Value

    Extra Thick
    CALLUS REMOVERS

    Salicylic acid

    • Callus removal treatment
    • Relieves against pressure & pain

    4 MEDICATED PATCHES/4 PADS

    Premier Value_Extra Thick Callus Removers_LFCLRETPV.jpg

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    medicated callus removers extra thick patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 mg  in 4 
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    VINYL ACETATE (UNII: L9MK238N77)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-230-044 in 1 PACKAGE; Type 0: Not a Combination Product02/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F02/12/2018
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Premier Brands of America (063849780)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Brands of America080051232relabel(68016-230) , repack(68016-230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alchemix Corporation615263956manufacture(68016-230)
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