Label: ANTIBACTERIAL HNAD SANITIZER- alcohol liquid

  • NDC Code(s): 71734-312-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES 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 June 16, 2020

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  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • decrease bacteria and germs on the hands
    • use when soap , towel and water are not available.
    • recommended for repeared use.
  • Warnings

    For external use only.

    Stop use and ask a doctor ifirritation or redness develops or persists.

    Flammable, keep away from fire or flame

    Do not apply around eyes.

    Do not use in ears and mouth

    Other information:

    • store at 20℃ (68 to 77 ℉)
    • may discolor fabrics

    avoid contact with eyes. In case of contact flush eyes with water

    consult a physicia

    if irritation or redness develops or persists

    Keep out of reach of children.

     Children under 6, use only under adult supervision. Not recommended for infants.

  • Directions

    • open the package, squeeze hand sanitizer into your palms and thoroughly spread on both hands
    • rub into skin until dry
  • Inactive Ingredients

    purified water, triethanolamine, glycerine, Disodium EDTA, carbomer

  • Product Labeling

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HNAD SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-312-013 mL in 1 DOSE PACK; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/16/2020
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534manufacture(71734-312)
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