Label: ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 March 16, 2015

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  • Active Ingredient

    ETHYL ALCOHOL 65%

  • Uses

    For handwashing to decrease bacteria on the skin.

  • Warnings

    For external use only.


  • When using this product

    Avoid contact with eyes. If contact occurs flush eyes with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.


  • Keep out of the reach of children

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

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping. Repeat as necessary. Supervise children with use of this product.

  • Inactive Ingredients

    Aminomethyl Propanol, Benzophenone-3, Carbomer, Deinized Aqua (water), Glycerin, Isopropyl Palmitate, Polyaminopropyl Biguanide, Propylene Glycol, Tocopheryll Acetate (Vitamin E).

  • HOW SUPPLIED

  • PRINCIPAL DISPLAY PANEL

    image of 15018

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43333-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    OXYBENZONE (UNII: 95OOS7VE0Y)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43333-451-06236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/16/2015
    Labeler - Tonic Bath and Body Products Shenzhen Ltd. (528197042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tonic Bath and Body Products Shenzhen Ltd.528197042manufacture(43333-451)