Label: DISINFECTING ALCOHOL WIPES cloth

  • NDC Code(s): 41546-010-01
  • Packager: Zhejiang Huanghua Biological Technology Co., Ltd
  • 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 September 9, 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 Do not place in direct sunlight or store in high-temperature environments
    2. Do not get into eyes; If contact occurs, rinse thoroughly with clean water
    3. Keep out of reach of children to avoid swal lowing and chocking hazards
    4. Do not throw away into the toilet; the wipes are not water soluble
    5. This product is for externaluse only
    6. Do not use product if allergic or suspend use if signs of allergies appear
    7. For commercial and industrial use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTING ALCOHOL WIPES 
    disinfecting alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-010
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL380 mL  in 100 
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.65 g  in 100 
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.65 g  in 100 
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.65 g  in 100 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.65 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41546-010-01100 in 1 BAG; Type 0: Not a Combination Product09/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/10/2020
    Labeler - Zhejiang Huanghua Biological Technology Co., Ltd (415467459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Huanghua Biological Technology Co., Ltd415467459manufacture(41546-010)
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