Label: MEIJER KIDS- benzalkonium chloride lotion

  • 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 September 21, 2013

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  • INACTIVE INGREDIENT

    Inactive Ingredients - Benzophenone - 4, Citric Acid, Cocamidopropyl

    Betaine, Frangrance (Parfum), Methylisothiazolinone, Phenoxyethanol, Red 33,

    Red 40, Sodium Lauroyle Glutamate, Sodium Lauroyle Sarcosinate,

    Tocopheryl Acetate, Water (Agua).


  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.20 %

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use - hand washing to decrease bacteria on skin

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product avoid contact with eyes. If

    contact occurs, rinse thoroughly with water.

  • STOP USE

    Discontinue use if irritation and redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical

    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions  -  wet hands --  work into rich later

    --rinse well

  • QUESTIONS

    Questions?  1 - 800 - FDA - 1088

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    MEIJER KIDS  
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.596 g  in 298 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOPHENONE (UNII: 701M4TTV9O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBLUEBERRY (Blueberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-003-01298 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2013
    Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-003)
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