Label: ALCOHOL DISINFECTANT WIPES 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 November 25, 2020

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  • DOSAGE & ADMINISTRATION

    Please do not place in direct sunlight or in a place with high temperature

  • INACTIVE INGREDIENT

    pure water

  • INDICATIONS & USAGE

    1.Open the box and seal it
    2.Take out all the wet tissues you need
    3.Close the box seal

  • ACTIVE INGREDIENT

    alcohol

    Benzalkamine

    2-methyl-4-isothiazoline-3-one

    propylene glyco

    2-phenoxyethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1.Please do not place in direct sunlight or in a place with high temperature
    2. lf it gets into your eyes, wash it with clean water immediately
    3. Keep out of reach of children to avoid swallowing and choking
    4.This product is insoluble in water, please do not throw into the toilet
    5.This product is for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT WIPES 
    alcohol disinfectant wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-004
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL126.5625 mL  in 50 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.715625 g  in 50 
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE3.65625 mg  in 50 
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1.2375 g  in 50 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.27806875 g  in 50 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41546-004-0150 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(41546-004)
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