HAND SANITIZER (ETHYL ALCOHOL) GEL [ATARA HOLDINGS INC]

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HAND SANITIZER (ETHYL ALCOHOL) GEL [ATARA HOLDINGS INC]
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NDC 71154-001-01
Set ID 44689ee0-5221-0689-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Atara Holdings Inc
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active Ingredient
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from fire or flame.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump as needed into your palms to cover hands. Rub hands together briskly unitl dry. Children under 6 years old should be supervised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, D&C Red No.33, FD&C Blue No.1.

  • INDICATIONS & USAGE

    Uses

    To help reduce bacteria on the skin.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71154-001
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71154-001-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product12/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/24/2016
    Labeler - Atara Holdings Inc (080473576)
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