RAGGEDY ANN AND ANDY FOAM (BENZALKONIUM CHLORIDE) SOAP [MY HABITAT BRANDS LLC]

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RAGGEDY ANN AND ANDY FOAM (BENZALKONIUM CHLORIDE) SOAP [MY HABITAT BRANDS LLC]
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NDC 75878-003-75
Set ID 44efbde0-d919-4a39-8e67-ca3b7aabc286
Category HUMAN OTC DRUG LABEL
Packager My Habitat Brands LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    • For hand washing and to decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    • For external use only.

    When using this product, keep out of eyes. In case of contact with eyes, immediately flush eyes with water. Avoid contact with broken skin.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Wet hands. Apply palm full to hands. Scrub thoroughly. Rinse. Recommended for repeated use.
  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Glycerin, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate, FD&C Yellow No.5

  • PRINCIPAL DISPLAY PANEL - 221ml Bottle Label

    Raggedy
    Ann&Andy™

    ANTIBACTERIAL
    FORMULA Enriched
    with Vitamin E

    FOAM HAND SOAP

    Vanilla
    Bean

    7.5 FL OZ (221ml)

    Principal Display Panel - 221ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    RAGGEDY ANN AND ANDY FOAM   VANILLA BEAN
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75878-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Glycerin (UNII: PDC6A3C0OX)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75878-003-75221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/20/2010
    Labeler - My Habitat Brands LLC (965398246)
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