Label: PEDI-QUICK ONE STEP CALLUS REMOVERS- salicylic acid plaster

  • 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 February 15, 2019

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  • ACTIVE INGREDIENT

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic Acid 40%

  • PURPOSE

    Purpose

    Callus remover

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only  Use only as directed

  • DO NOT USE

    Do Not Use this product

    • on irritated skin, or on any area that is infected or reddened
    • if you are diabetic
    • if you have poor blood circulation
  • ASK DOCTOR/PHARMACIST

    If discomfort persists, see your doctor or podiatrist

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • Wash affected area. Soak in warm water for five minutes, if desired. Dry thoroughly.
    • Remove bandage from backing
    • Apply with medicated area directly over callus
    • After 48 hours remove medicated bandage
    • Repeat procedure every 48 hours as needed (until callus is removed) for up to 14 days.
  • OTHER SAFETY INFORMATION

    Other information  Store between 59 o and 86 o F (15 o and 30 o C)

  • INACTIVE INGREDIENT

    Inactive Ingredients Polyvinyl Alcohol, Acrylic Copolymer

  • QUESTIONS

    Questions or Comments?  CALL 1-800-Pedifix (733-4349)

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PEDI-QUICK ONE STEP CALLUS REMOVERS 
    salicylic acid plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17.67 mg  in 44.18 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68927-3295-11 in 1 CONTAINER07/07/2017
    14 in 1 CELLO PACK
    144.18 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B07/07/2017
    Labeler - PEDIFIX, INC. (122271935)
    Registrant - PEDIFIX, INC. (122271935)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEDIFIX, INC.122271935pack(68927-3295)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akron Coating & Adhesive186569323manufacture(68927-3295)
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