Label: ALCOHOL DISINFECTANT WIPES cloth

  • Category: HUMAN OTC DRUG LABEL

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 December 7, 2020

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  • DOSAGE & ADMINISTRATION

    store between 15-30°C(59-86°F)
    avoid freezing and excessive heat above 40°C(104°F)

  • INACTIVE INGREDIENT

    pure water

  • INDICATIONS & USAGE

    open the package lid and wipe skin until dry.

  • ACTIVE INGREDIENT

    alcohol

    Benzalkamine

    2-methyl-4-isothiazoline-3-one

    propylene glyco

    2-phenoxyethanol

  • DO NOT USE

    For children less than 2 months of age.

    On open skin wounds.

  • 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.

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • STOP USE

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

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT WIPES 
    alcohol disinfectant wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL160 mL  in 50 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 50 
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.5 g  in 50 
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.5 g  in 50 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.5 g  in 50 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41546-016-0150 in 1 BAG; Type 0: Not a Combination Product11/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/26/2020
    Labeler - Zhejiang Huanghua Biological Technology Co., Ltd (415467459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Huanghua Biological Technology Co., Ltd415467459manufacture(41546-016)
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