Label: MY LITTLE PONY HAND SANITIZER SET- benzalkonium chloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 3, 2017

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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

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  • INGREDIENTS AND APPEARANCE
    MY LITTLE PONY HAND SANITIZER SET 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58737-217
    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
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    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
    FlavorBERRY, GRAPE, BUBBLE GUM, BLUEBERRY, WATERMELON, STRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58737-217-0159 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2017
    Labeler - Townley Inc. (016956158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co., Ltd.421222423manufacture(58737-217)
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