Label: ANTIBACTERIAL HAND SANITIZER- alcohol gel

  • NDC Code(s): 71734-309-01, 71734-309-02, 71734-309-03, 71734-309-04, view more
    71734-309-05
  • 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 May 2, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol       62%

  • Purpose

     Antiseptic

  • Use

    Hand sanitizer to help decrease bacteria on the skin.

    When water, soap and towel are not available

    Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame

    Do not apply around eyes.

    Do not use in ears and mouth.

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor If redness or irritation develop and persist for more than 72 hours

    Keep out of reach of children.

    children must be supervised in use of this product.

  • Directions

    Pump as needed into your palms and thoroughly spread on both hands.

    Rub into skin until dry.

  • Inactive ingredients

    Pure Water, Triethanolamine, Glycerin, Disodium EDTA, Carbomer

  • SPL UNCLASSIFIED SECTION

    Other Information

    Store at 20 ℃  （68 to 77 ℉).

    May discolor fabrics.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-309
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-309-0154 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2020
    2NDC:71734-309-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2020
    3NDC:71734-309-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2020
    4NDC:71734-309-04238 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2020
    5NDC:71734-309-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/02/2020
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534manufacture(71734-309)
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