Label: ANTIBACTERIAL HAND SANITIZER- alcohol liquid

  • 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 February 9, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 73% v/v

    Purpose

    Antimicrobial

  • Use:

    Hand sanitizer to help reduce bacteria on skin.

  • Warnings:

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

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor

    if irritation or rash appears and lasts.

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions:

    Put enough product in your palm to cover hands and rub hands together briskly until dry.

    Children under 6 years of age should be supervised when using

  • Other information:

    Store below 110°F (43°C)

  • Inactive ingredients:

    Deionized Water, Glycerol, Carbopol, Triethanolamine

  • Package Labeling: 250ml

    Label

  • Package labeling 60mL

    60mL

  • Package Labeling 120mL

    120mL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77879-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.73 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77879-001-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    2NDC:77879-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    3NDC:77879-001-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/27/2020
    Labeler - BT Supplies West Inc (033878488)
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