Label: ANTIBACTERIAL HAND SANITIZER- ethyl 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 November 11, 2020

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  • Active ingredient

    Ethyl alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on the skin.
    • recommended for repeated use.
  • Warnings

    For external use only.

  • When using this product

    • Do not use in eyes.
    • Discontinue use if irritation and redness develop.
    • Flammable, keep away from fire or flame.
  • Keep out of reach of children

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

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    • wet hands thoroughly with product.
    • briskly rub hands together until dry.

  • Inactive Ingredients

    Water, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Aloe Barbadensis Leaf Juice, Maltodextrin, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73145-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73145-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/11/2020
    Labeler - ASC Marketing Ltd. (117025198)
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