Label: BERRY SCENTED HAND SANITIZER GIRL- 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 April 3, 2015

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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

    May Contain

    Red 40 (Cl 16035)

    Red 33 (Cl 17200)

    Blue 1 (Cl42045)

    Yellow 5 (Cl 19140)

  • 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 etyher, carbomer, sodium hydroxide, peg-40 hydrogenated castor oil, fragrance/parfum.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    BERRY SCENTED HAND SANITIZER  GIRL
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54860-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.06 mg  in 59 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY, BERRY, APPLE, RASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54860-018-0159 mg in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/29/2013
    Labeler - Shenzhen Lantern Science Co., Ltd. (421222423)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co., Ltd.421222423manufacture(54860-018)
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