Label: ANTI-BACTERIAL HAND- 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 July 16, 2020

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  • ACTIVE INGREDIENT

    Active ingredient               Ethyl Alcohol       ...........         62% W/W 

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    • Hand sanitizer to help decrease bacteria on the skin.
    • recommended for repeated use
  • WARNINGS

    For external use only - hands
    Flammable. Keep away from heat or flame.

    When using this product avoid contact with eyes and nose. In case of contact flush eyes with water.

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

  • DOSAGE & ADMINISTRATION

    wet hands thoroughly with product and allow to dry.

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74149-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74149-024-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/16/2020
    Labeler - Yiwu Yangjie Daily Chemicals Co.,Ltd. (529648827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Yangjie Daily Chemicals Co.,Ltd.529648827manufacture(74149-024)
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