Label: 70%ALCOHOL WET WIPES- antibacterial antiseptic wet wipes cloth

  • NDC Code(s): 80638-260-48
  • Packager: FRESH CO COSMETICS SH.P.K
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    70% ALCOHOL WET WIPES

    Antibacterial ANTISEPTIC WET WIPES

    trusted protection

  • Use

    Sanitize and decreases bacteria on skin

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    keep out of eyes, ears, and mouth, In case of contact with eyes, rinse eyes thoroughly with water

  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours. 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.1-800-222-1222

    adults and childrens 2 years & over - apply to hands, wet hands thoroughly with product and allow it to dry

    Children under 2 years - ask a doctor before use

  • Directions for use

    • to dispense peel back front label slowly remove wipes
    • to reseal pouch firmly run thumb over the label
    • dont flush
  • Other information

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

    Water, glycerin,tocopheryl acetate ( vitamin E), Panthenol

  • Package Label - Principal Display Panel

    48 wipesNDC: 80638-260-48

  • INGREDIENTS AND APPEARANCE
    70%ALCOHOL WET WIPES 
    antibacterial antiseptic wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80638-260
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.18 mL  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80638-260-48260 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/01/2020
    Labeler - FRESH CO COSMETICS SH.P.K (499428868)
    Registrant - FRESH CO COSMETICS SH.P.K (499428868)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRESH CO COSMETICS SH.P.K499428868manufacture(80638-260)
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