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 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

    1.Open cover and remove seal.
    2.Pull out wipe corner from center of the roll.
    3.Thread through hole in the cover.
    4.Close lid after use to retain moisture.

  • 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

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • 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:41546-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL315 mL  in 80 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE7.4 g  in 80 
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE7.4 g  in 80 
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL7.4 g  in 80 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL7.4 g  in 80 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41546-018-0180 in 1 PACKET; Type 0: Not a Combination Product11/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/25/2020
    Labeler - Zhejiang Huanghua Biological Technology Co., Ltd (415467459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Huanghua Biological Technology Co., Ltd415467459manufacture(41546-018)
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