Label: FARMACY ANTISEPTIC HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 18, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: ETHANOL 70% v/v

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Glycerin, Carbomer, Dipropylene Glycol, Isopropylene Myristate, Triethanolamine, Citrus Paradisi (Grapefruit) Seed Extract, Aloe Barbadensis Leaf Juice Powder

  • PURPOSE

    Purpose: ANTISEPTIC

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat and flame
    --------------------------------------------------------------------------------------------------------
    When using this product
    keep out of eyes, ears, and mouth.
    if contact occurs, rinse eyes thoroughly with water
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor
    if irritation or rash occurs.

  • 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.

  • Uses

    Uses

    Hand sanitizer to help reduce bacteria on skin only when water and soap is not available

  • Directions

    Directions

    • Wet hands throughly with product and rub hands together until dry
    • Supervise children under 6 years of age when using.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    FARMACY ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73819-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Dipropylene Glycol (UNII: E107L85C40)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Trolamine (UNII: 9O3K93S3TK)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73819-0005-160 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - GuStar Co Ltd (694234583)
    Registrant - GuStar Co Ltd (694234583)
    Establishment
    NameAddressID/FEIBusiness Operations
    GuStar Co Ltd694234583manufacture(73819-0005)
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