Label: HAND SANITIZER gel

  • NDC Code(s): 50157-569-01, 50157-569-02, 50157-569-03
  • Packager: Brands International
  • 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 April 7, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl alcohol 62%.

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings

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

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

  • DOSAGE & ADMINISTRATION

    Directions

    Spread on both hands, rub in, let dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water, Isopropyl Myristate, Aminomethyl Propanol.

    Please review individual labels for specific details on colors and additives on 3 different variety of sanitizers.

  • Packaging

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    Untitlede

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-569
    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
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE (UNII: V5VD430YW9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-569-011 in 1 KIT03/04/2020
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50157-569-021 in 1 KIT03/04/2020
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50157-569-031 in 1 KIT03/04/2020
    359 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2020
    Labeler - Brands International (243748238)
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