Label: ANTIBACTERIAL ANTISEPTIC WET WIPES cloth

  • NDC Code(s): 80638-600-01
  • 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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  • ANTIBACTERIAL ANTISEPTIC WIPES 120 PCS

    ANTIBACTERIAL ANTISEPTIC WET WIPES TRUSTED PROTECTION

  • Active Ingredient(s)

    BENZALKONIUM CHLORIDE 0.13 % v/v. Purpose: Antiseptic

  • Purpose

    ANTIBACTERIAL ANTISEPTIC WET WIPES

  • Use

    DECREASES BACTERIA ON SKIN FOR USE WHEN SOAP AND WATER NOT AVAILABLE

  • Warnings

    For external use only.

  • Do not use

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

    When using this product do not get into eyes, ears and mouth if contact occurs rinse eyes thoroughly with water.

  • STOP USE

    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

  • Directions

    adults and children 2 years and 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

    do not flush

  • Other information

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

    deoinised water, cetearyl isononanoate, ceteareth-20, cetearyl alcohol, glyceryl stearate,glycerine, ceteareth-12, cetyl palmitate, phenoxyethanol,sodium benzoate, fragrance, citric acid, disodium EDTA

  • Package Label - Principal Display Panel

    120 wipes600 mL NDC:80638-600-01

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL ANTISEPTIC WET WIPES 
    antibacterial antiseptic wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80638-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.03 mL  in 100 mL
    CETEARYL ISONONANOATE (UNII: P5O01U99NI) 0.03 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.03 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.03 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 99.52 mL  in 100 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.03 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.01 mL  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.03 mL  in 100 mL
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E) 0.01 mL  in 100 mL
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 0.01 mL  in 100 mL
    CETEARETH-12 (UNII: 7V4MR24V5P) 0.01 mL  in 100 mL
    CETYL PALMITATE (UNII: 5ZA2S6B08X) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80638-600-01600 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.K.499428868manufacture(80638-600)
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