Label: THEOCHEM TEA TREE HAND AND BODY WASH- tea tree hand and body wash soap

  • 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 October 8, 2013

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  • Active Ingredient

    Triclosan 0.2%

  • Purpose:

    Antimicrobial

  • Uses:

    For hand washing to decrease bacteria on the skin.

  • Warnings:

    For external use only.

    When using this product, do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    For use  applications, pump dispenser a few times to prime. Wet hands and dispense a small amount of the foamimg product into palm.

    Work soap into a rich, foamy lather. Rinse with water.

  • Other Information:

    Hand washing to decrease bacteria on skin. Recommended for repeated use. 

  • Inactive Ingredients:

    Water, Sodium Lauryl Sulfate, Sodium Lauryl Ether Sulfate, Cocamidopropyl Betaine, Tetrasodium Salt of Ehylenediamine Tetraacetic Acid, Glycerine, Propylene Glycol, Aloe Extract, FD&C Blue # 1, FD&C Yellow # 5, Fragrance, 1, 2-benzisothiazolin-3-one and 2-methyl-4-isothiazolin-3-one 

  • PRINCIPAL DISPLAY PANELTEA TREE HAND AND BODY WASHNET CONTENTS: 1250 ml

    Tea Tree 1250 ml

  • INGREDIENTS AND APPEARANCE
    THEOCHEM TEA TREE HAND AND BODY WASH 
    tea tree hand and body wash soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68878-140
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68878-140-211250 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2008
    Labeler - Theochem Laboratories Inc (004100038)
    Registrant - Theochem Laboratories Inc (004100038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teochem Laboratories Inc004100038manufacture(68878-140)
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