HAND SANITIZER (ETHYL ALCOHOL) GEL [DZA BRANDS LLC]

HAND SANITIZER (ETHYL ALCOHOL) GEL [DZA BRANDS LLC]
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NDC 55316-253-03
Set ID 56bebada-75e8-4d6c-a7f8-2139b07b09f4
Category HUMAN OTC DRUG LABEL
Packager DZA Brands LLC
Generic Name
Product Class
Product Number
Application Number PART333E
  • Active ingredient

    Ethyl Alcohol 65%

    Purpose

    Antiseptic

  • Uses

    • to help reduce bacteria on the skin
  • Warnings

    • For external use only.
    • Flammable, keep away from fire or flame

    When using this product

    • avoid contact with eyes.
    • if contact occurs, rinse with water.

    Stop using and ask a doctor

    • if irritation or redness develops and lasts.

    Keep out of reach of children.

    • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply a small amount in your palm and rub hands together briskly until dry. Children under 6 should be supervised when using this product.
  • Other information

    do not store above 110°F (43°C)

  • Questions/comments?

    1-866-322-2439

  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Actate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-253-0359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/27/2017
    Labeler - DZA Brands LLC (090322194)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(55316-253)

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