Label: ANTI-BACTERIAL HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 72707-029-01
  • Packager: DISNEY DESTINATIONS,LLC
  • 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 September 3, 2020

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  • Active ingredient

    Ethyl Alcohol 63%

  • Purpose

    Antiseptic

  • Uses

    To help reduce bacteria on hands.

  • Warnings

    • For external use only.
    • Flammable, keep away from fire, flame and direct sunlight.
  • When using this product

    • Avoid contact with eyes and lips.
    • If contact occurs, rinse with water.
  • STOP USE

    Stop use and ask a doctor if if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    • Place enough to cover both hands in the palm, and rub hands together until dry.
    • Children under 6 years of age should be supervised by adults when applying this product.

  • Inactive ingredients:

    aminomethyl propanol, carbomer, denatonium benzoate, glycerin, propylene glycol, water.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72707-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72707-029-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2020
    Labeler - DISNEY DESTINATIONS,LLC (079603310)
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