VISIBLY CLEAN HAND SANITIZER (ALCOHOL) SOLUTION [BRANDS INTERNATIONAL]

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VISIBLY CLEAN HAND SANITIZER (ALCOHOL) SOLUTION [BRANDS INTERNATIONAL]
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NDC 50157-100-01
Set ID 44f8b020-7755-466f-bf0b-a75d3b11979d
Category HUMAN OTC DRUG LABEL
Packager Brands International
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help reuce bacteris on the skin
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if: irritation and redness develops.

  • 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.

  • Directions

    • apply palmful to hands
    • rub hands together vigorously until dry
    • supervise children in the use of this product.
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf juice (Aloe Vera), Tocopheryl Acetate (Vitamin E)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Brands International Corp.
    Markham, ON, L6G 1B9 Canada
    www.brandsicorp.com

  • Package Label

    3SENI

  • PRINCIPAL DISPLAY PANEL

    2SENI

  • PRINCIPAL DISPLAY PANEL

    1SENI

  • INGREDIENTS AND APPEARANCE
    VISIBLY CLEAN HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-100
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-100-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2014
    2NDC:50157-100-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2014
    3NDC:50157-100-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/15/2014
    Labeler - Brands International (243748238)
    Registrant - Brands International (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture(50157-100)
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