MY LITTLE PONY COTTON CANDY SCENTED (BENZALKONIUM CHLORIDE) GEL [TOWNLEY INC.]

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  • MY LITTLE PONY COTTON CANDY SCENTED (BENZALKONIUM CHLORIDE) GEL [TOWNLEY INC.]

MY LITTLE PONY COTTON CANDY SCENTED (BENZALKONIUM CHLORIDE) GEL [TOWNLEY INC.]
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NDC 58737-219-01
Set ID 575a4d9a-4dd1-9b6e-e053-2a91aa0a5e1f
Category HUMAN OTC DRUG LABEL
Packager Townley Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Use

    To decrease bacteria on the skin that could cause disease

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime sized drop into hands.
    • For children under 6 use under adult supervision.
  • 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.
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance, may contain: red 40, red 33, blue 1, yellow 5.

  • PRINCIPAL DISPLAY PANEL

    text

  • INGREDIENTS AND APPEARANCE
    MY LITTLE PONY COTTON CANDY SCENTED 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58737-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCETH-7 (UNII: 58Y261JLH5)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58737-219-0159 g in 1 BOTTLE; Type 0: Not a Combination Product08/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2017
    Labeler - Townley Inc. (016956158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Jinxiong Technology Co ., Ltd.544328419manufacture(58737-219)
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