Label: ANTIBACTERIAL HAND SANITIZER gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 18, 2020

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  • Active Ingredients

    Glutaraldehyde 0.3%, AES 7.0%, APG 1.0%, AEO-9 0.5%, CAB 3.8%

  • Purpose


    Antibacterial

  • Uses


    For hand sanitizing to reduce bacteria on the skin.

  • Warnings


    For extermal use only-hands. Flamable. Keep aways from heat and flame.

  • Do not use


    in children less than 2 months of ageon open skin wounds

  • WHEN USING

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • Directions


    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

  • Inactive Ingredients

    Water, Salt, Citric Acid

  • Package Label - Principal Display Panel

    1234

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75129-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLUTARAL (UNII: T3C89M417N) (GLUTARAL - UNII:T3C89M417N) GLUTARAL0.3 g  in 100 mL
    CARBONIC ANHYDRASE 1 (UNII: 31F7ZV0E20) (CARBONIC ANHYDRASE 1 - UNII:31F7ZV0E20) CARBONIC ANHYDRASE 13.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75129-002-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    2NDC:75129-002-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    3NDC:75129-002-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    4NDC:75129-002-045000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/18/2020
    Labeler - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)
    Registrant - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Rayshine ENVI-TECH Developing CO., Ltd.420836386manufacture(75129-002)