Label: PREMIER SOLUTIONS LIQUID CORN AND CALLUS REMOVER- salicylic acid liquid

  • NDC Code(s): 56104-255-01
  • 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 25, 2023

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  • Active ingredient

    Salicylic acid 17%w/w

  • Purpose

    Corn and callus remover

  • Uses

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

    For external use only.

    Flammable

    • keep away from fire or flame
    • cap bottle tightly and store at room temperature away heat

    Do not use

    • on irritated skin
    • on any area that is infected or reddened
    • if you are a diabetic, or if you have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

    When using this product

    • avoid contact with eyes
    • avoid inhaling vapors
    • if product gets into the eyes, flush with water for 15 minutes

    Stop and ask a doctor if

    discomfort persists, see your doctor or podiatrist

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash the affected area and dry thoroughly
    • carefully apply one drop at a time with applicator to sufficiently cover each corn/callus
    • do not apply to face or neck
    • let dry
    • use cushion with hole centered over corn or callus to relieve pressure (additional cushions may be purchased separately)
    • repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
    • may soak corn/callus in warm water for 5 minutes to assist in removal
  • Other information

    • store between 20°C to 25°C (68°F to 77°F)
    • Close tightly to prevent solidification
    • Store in a cool place

  • Inactive ingredients

    camphor, castro oil, ethanol, ethyl ether, nitrocellulose

  • Questions?

    Call 1- 866-964-0939

  • Principal Display Panel

    Premier Solutions

    liquid corn & callus remover

    salicylic acid 17%

    safely removes corn & calluses

    soft foam cushions & protects

    3 Cushions

    0.33 FL OZ (9.8 mL)

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  • INGREDIENTS AND APPEARANCE
    PREMIER SOLUTIONS LIQUID CORN AND CALLUS REMOVER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.17 mg  in 9.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    PYROXYLIN (UNII: KYR8BR2X6O)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ETHER (UNII: 0F5N573A2Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-255-019.8 mL in 1 PACKAGE; Type 0: Not a Combination Product06/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F06/15/2022
    Labeler - Premier Brands of America Inc. (117557458)
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