JUSTICE BERRY SCENTED ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) GEL [TWEEN BRANDS, INC.]

JUSTICE BERRY SCENTED ANTI-BACTERIAL HAND SANITIZER (ALCOHOL) GEL [TWEEN BRANDS, INC.]
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NDC 60637-219-30
Set ID 8a465ff2-5cb5-43bc-a9a7-d4e2162ac90d
Category HUMAN OTC DRUG LABEL
Packager Tween Brands, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
  • Active Ingredient

    Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

    Recommended for repeated use

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

  • Warnings

    Flammable, keep away from fire or flame

    For external use only. Do not use in the eyes the eyes or apply 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 directed. Do not drink. If taken internally, it will produce serious gastric disturbance

    Stop use and ask a doctor if irritation persists for more than 72 hours

    Keep out of reach of children

    If swallowed gel medical helpo r contact a Poison Control Center right away

    Supervise children in the use of this product

  • Inactive ingredients

    Water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, polyethylene terephthalate, acrylates copolymer, FD&C red No. 40, D&C Red No. 33

  • PRINCIPAL DISPLAY PANEL

    package labellabel

  • INGREDIENTS AND APPEARANCE
    JUSTICE BERRY SCENTED ANTI-BACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60637-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    2,4-D-TROLAMINE (UNII: E6SLK39VZN)  
    POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) (UNII: Y78AJD3DED)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60637-219-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/20/2018
    Labeler - Tween Brands, Inc. (965758188)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(60637-219)

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