Label: CALLICIDE CORN AND CALLUS REMOVER- salicylic acid ointment

  • 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 September 16, 2013

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  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 17%

  • PURPOSE

    Purpose

    Corn and callus remover

  • INDICATIONS & USAGE

    Uses

    for the removal of corns and calluses; relieves pain by removing corns and calluses.

  • WARNINGS

    Warnings:

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C yellow #11, methylparaben, methyl salicylate, propylparaben, white petrolatum

  • DO NOT USE

    Tamper Evident

    Do not use if seal is broken or missing.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a thin coat of the medication to cover the entire wart, callus, or corn using the applicator if provided. Be careful to apply it only to the affected area and not the surrounding skin. Let dry for 5 minutes. Repeat this procedure 1 to 2 times daily for up to 2 weeks for corns and calluses and 12 weeks for warts or as directed by your doctor.

  • PRINCIPAL DISPLAY PANEL

    Callicide Label

  • INGREDIENTS AND APPEARANCE
    CALLICIDE CORN AND CALLUS REMOVER 
    salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-022-051 in 1 CARTON
    128.4 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B02/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
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