Label: PURE WIPES 70 ALCOHOL WIPES- isopropyl alcohol cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 5, 2021

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  • DRUG FACTS

  • Active Ingredient

    Isopropyl Alcohol 70%

    Purpose

    First Aid Antiseptic Wipes

  • USES

    First aid to help prevent the risk of infection in minor cuts, scrapes, and burn.

  • DIRECTIONS

    Clean the affected area. Apply product on the affected area of the body 1 to 3 times a day. May be covered with sterile bandgae. If bandage, let dry first.

  • WARNING

    FOR EXTERNAL USE ONLY. Do not apply internally.

    FLAMMABLE Keep product away from direct sunlight, heat, flame/fire, spark & electricity.

    When using this product

    Do not get into eyes. Do not apply over large areas. do not use longer than one week unless directed by physician.

    KEEP OUT OF REACH OF CHILDREN

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

  • Other Information

    Keep canister tightly closed. Store at room temperature. Hold away from face when opening

  • INACTIVE INGREDIENT

    Purified water

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    PURE WIPES 70 ALCOHOL WIPES 
    isopropyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74830-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74830-003-01160 in 1 CANISTER01/01/2021
    14.375 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2021
    Labeler - Economy Polymers and Chemicals (008087603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Economy Polymers and Chemicals008087603manufacture(74830-003)
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