Label: ANTIBACTERIAL HAND SANITIZER- 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 April 20, 2020

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  • INDICATIONS & USAGE

    for hand washing to decrease bacteria on the skin only when water is not available.

  • Drug Facts Active Ingredients

    Alcohol Denat. 80%

  • Purpose

    Antiseptic

  • DOSAGE & ADMINISTRATION

    • Place enough product in your plam to thoroughly cover your hands. Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when this product to avoid swallowing
  • Inactive Ingredients:

    Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomthyl Propanol

  • Warning

    • For External Use Only.
    • Flammable, keep away from heat or flame
  • WHEN USING

    When using this product

    • Keep out of eyes, ears, and mouth. In case of contact with eyes thoroughly with water.
  • STOP USE

    Stop use and ask a doctor

    • if irritation or rash occurs. These may be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

  • DO NOT USE

    • In children less than 2 months of age.
    • On open skin wounds
  • OTHER SAFETY INFORMATION

    • Store at 68 to 77F (20-25C)
    • Do not store above 100F (43C)
    • You may report a serious advers reaction to Centric Beauty LLC, 350 5th Avenue, New York, NY 10118
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51522-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51522-003-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/11/2020
    Labeler - Gold Orient International Limited (679905914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gold Orient International Limited679905914manufacture(51522-003)
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