RAGGEDY ANN AND ANDY (TRICLOSAN) SOAP [MY HABITAT BRANDS LLC]

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RAGGEDY ANN AND ANDY (TRICLOSAN) SOAP [MY HABITAT BRANDS LLC]
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NDC 75878-002-30
Set ID a39ecc1b-7357-47ad-b447-e5bc2ac31dff
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

    Triclosan 0.2%

  • 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 palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use.
  • Inactive Ingredients

    Water, Sodium Lauryl Ether Sulfate,Cocamide DEA,Cocamidopropyl Betaine, Sodium Chloride, Disodium EDTA, Citric Acid,Fragrance, Methylchloroisothiazolinone and Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL - 300ml Bottle Label

    Raggedy
    Ann&Andy™

    Tropical Breeze
    ANTIBACTERIAL
    HAND SOAP

    10.1 FL OZ
    (300ml)

    Principal Display Panel - 300ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    RAGGEDY ANN AND ANDY   TROPICAL BREEZE
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75878-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.002 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    Coco Diethanolamide (UNII: 92005F972D)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    sodium chloride (UNII: 451W47IQ8X)  
    edetate disodium (UNII: 7FLD91C86K)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75878-002-30300 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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