TROLLS 4 PACK HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [TOWNLEY, INC.]

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TROLLS 4 PACK HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [TOWNLEY, INC.]
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NDC 58737-178-01
Set ID 3ae8badf-f968-62fd-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Townley, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose: Antibacterial

  • PURPOSE

    Use

    To decrease bacteria on the skin that could cause disease.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Hand Sanitizer

    2 FL OZ (59mL)

  • WARNINGS

    Warnings

    • for external use only-hands.
    • keep out of eyes. avoid contact with broken skin.
    • stop use and ask a Doctor if irritation or redness develops.
    • do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime sized drop into hands.
    • For children under 6 use under adult supervision.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water (aqua/eau), glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, triethanolamine, PEG-40 hydrogenated castor oil, fragrance (parfum).

    May Contain

    Red 40 (CI 16035), Red 33 (CI 17200), Blue 1 (CI 42090), Yellow 5 (CI 19140).

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    TROLLS 4 PACK HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58737-178
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 g  in 59 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCETH-7 CARBOXYLIC ACID (UNII: 35KO064932)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    METHOXY PEG-40 (UNII: 6AXS45P1QU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE, APPLE, VANILLA, BLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58737-178-0159 g in 1 BOTTLE; Type 0: Not a Combination Product08/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/25/2016
    Labeler - Townley, Inc. (016956158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Townley, Inc.016956158manufacture(58737-178)
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