WATERMELON ANTI BACTERIAL HAND SANITIZER (ALCOHOL) GEL [B2 FASHIONS INC.]

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WATERMELON ANTI BACTERIAL HAND SANITIZER (ALCOHOL) GEL [B2 FASHIONS INC.]
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NDC 71372-004-30
Set ID 4c6c7b25-b89e-483a-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager B2 Fashions Inc.
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 decrease bacteria on the skin.
    • When water, soap & towel are not available.
    • recommended for repeated use
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes.

    Do not use

    in ears & mouth

    When using this product,

    avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if

    redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • pump as needed into your palms and thoroughly spread on both hands.
    • rub into skin until dry.
  • Other information

    • store at 20° C (68° to 77° F).
    • may discolor fabrics. 
  • Inactive ingredients

    Water (Aqua), Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Gel, Tocopheryl Acetate, Fragrance (Parfum), FD&C Blue 1, D&C Red 33.

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    WATERMELON ANTI BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71372-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71372-004-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/05/2017
    Labeler - B2 Fashions Inc. (243904310)
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