Label: ANTI-BACTERIAL 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 November 24, 2021

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  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on the hand
  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame
    • Do not use in the eyes

    Stop use and ask a doctor if:

    • Irritation and redness develop
    • Condition presists more than 72 hours

  • Keep out of reach of children.

    • If swallowed, get medical help or contact Poison Control Center right away. 
  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other Information

    Store between 59-86°F (15-30°C)

    Avoid freezing and excessive heat above 104°F (40°C)

  • Inactive ingredients

    Carbomer, Glycerol, Aminomethyl Propanol, Propylene Glycol , Aqua.

  • Product Image

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77027-113
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77027-113-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/16/2021
    Labeler - GUANGZHOU ZUOFUN COSMETICS CO., LTD. (530135094)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU ZUOFUN COSMETICS CO., LTD.530135094manufacture(77027-113)
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