Label: PUREXX IPA WIPES- isopropyl alcohol cloth 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 January 29, 2021

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  • SPL UNCLASSIFIED SECTION

    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.

  • Active Ingredient(s)

    Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Sterile antiseptic wipe recommended for single use.

    For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • In children less than 2 months of age
    • As a diaper wipe
    • On open skin wounds
    • In eyes. In case of contact, rinse eyes thoroughly with water
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wipe over the skin or affected area, recommended for single-use, properly dispose of the used wipe.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water, Hydrogen Peroxide, Glycerin, Fragrance.

  • Package Label - Principal Display Panel

    10 in 1 PACKET NDC: 74988-202-10 10


    50 in 1 PACKET NDC: 74988-202-50 50


    72 in 1 PACKET NDC: 74988-202-72 72


    100 in 1 PACKET NDC: 74988-202-99 100

    75 in 1 CANISTER NDC: 74988-202-75 75

  • INGREDIENTS AND APPEARANCE
    PUREXX IPA WIPES 
    isopropyl alcohol cloth cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74988-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74988-202-1010 in 1 PACKET; Type 0: Not a Combination Product09/09/2020
    2NDC:74988-202-5050 in 1 PACKET; Type 0: Not a Combination Product09/09/2020
    3NDC:74988-202-7272 in 1 PACKET; Type 0: Not a Combination Product09/09/2020
    4NDC:74988-202-99100 in 1 PACKET; Type 0: Not a Combination Product09/09/2020
    5NDC:74988-202-7575 in 1 CANISTER; Type 0: Not a Combination Product01/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/09/2020
    Labeler - SanitizeNow Inc. (117475870)
    Establishment
    NameAddressID/FEIBusiness Operations
    SanitizeNow Inc.117475870manufacture(74988-202)
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