Label: ANTIBACTERIAL HAND SANITIZER- alcohol gel

  • NDC Code(s): 70412-133-15, 70412-133-30
  • Packager: Zhejiang Ayan Biotech Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • For Hand Sanitizing

  • Warnings

    For external use only-hands.

    Flammable. Keep away from heat and flame.

    When using this product

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping. • For children under 6 age use only under adult supervision.

    • Not recommended for infants.

  • Other Information

    • Do not store above 105°F. • May discolor some fabrics.

  • Inactive Ingredients

    Carborner, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water. Yellow 5 (CI 19140), Blue 1 (CI 42090)

  • Package Labeling: 70412-133-15

    Label5

  • Package Labeling: 70412-133-30

    Label6

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-133-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/2020
    2NDC:70412-133-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/17/2020
    Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co.,Ltd.544377996manufacture(70412-133)
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