Label: ADVANCED HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 24, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 72%

    Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin
    • Recommended for repeated use
  • Warnings

    • Flammable, Keep away from fire or flame.
    • For external use only.

    Do not use 

    • in or near the eyes. in case of contact, flush eyes with water.

    Stop use and ask a doctor if

    • irritation or rash appears and lasts.

    Keep out of reach of children.

    • If need, get medical help or contact a Poison Control Center.
  • Directions

    • Wet hands thoroughly with enough product and allow to dry without wiping.
    • Children under 6 years of age use only under adult supervision when using this product.
  • Other information

    • Store below 105°F(43 C)
    • Surface to wood and plastics.
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Glycerin, Aloe barbadensis leaf extract, Carbomer, Tocopheryl Acetate, Triethanolamine.

  • Package Labeling: 59mL

    Bottle

  • Package Labeling: 236mL

    Label2

  • Package Labeling: 295mL

    Bottle3

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75311-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.72 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75311-000-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
    2NDC:75311-000-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
    3NDC:75311-000-03295 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/31/2020
    Labeler - UNISOURCES GROUP LLC (117474227)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Huiji Biotechnology Co., Ltd.526893497manufacture(75311-000)
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