JUSTICE LETTER R BLUEBERRY SCENT ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) GEL [TWEEN BRANDS, INC.]

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JUSTICE LETTER R BLUEBERRY SCENT ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) GEL [TWEEN BRANDS, INC.]
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NDC 60637-047-30
Set ID e9145e3e-e186-440a-ac00-a8fe902847e1
Category HUMAN OTC DRUG LABEL
Packager Tween Brands, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active Ingredient

    Alcohol 62%

    Purpose

    Antiseptic

  • Use

    • For hand washing to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    Flammable, keep away from fire or flame.

    For external use only. Do not use in the eyes or apply over large areas of the body.

    In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances

    Stop use and ask a doctor if

    irritation persists for more than 72 hours.

    Supervise children in the use of this product.

  • Other Information

    • Store beow 105 0F (40.5 0C)
    • May discolor some fabrics.
  • Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Inactive Ingredients

    Water, Glycerin, Propylene Glycol, Fragrance, Carbomer, Triethanolamine, FD&C Blue No. 1 (CI 42090)

  • Package Labeling:

    CartonBottleletter R

  • INGREDIENTS AND APPEARANCE
    JUSTICE LETTER R BLUEBERRY SCENT ANTI-BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60637-047
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60637-047-301 in 1 CARTON09/30/2015
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/30/2015
    Labeler - Tween Brands, Inc. (965758188)
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