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 3, 2013

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  • Active Ingredient

    Triclosan 0.2%

  • Purpose:

    Antimicrobial

  • Uses:

    For Hand Washing, and to decrease bacteria on the skin.

    Recommended for repeated use.

  • 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 with Dispenser:

    Pour contents into the dispenser reservoir. For first use applications, pump dispenser a few times to prime.

    For use as Hand Soap:

    Wet hands and dispense a small amount of the product into palm. Rub hands to produce lather. Rinse thoroughly with water, then dry hands completely.

    For use as Bath and Body Wash:

    Apply sparingly. Avoid contact with eyes. Lather and rinse.

  • Other Information

    Store at room temperature. Avoid extremes of both hot and cold.

  • Inactive Ingredients:

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Tetrasodium Salt of Ethylenediamine 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 PANEL

    TEA TREE HAND & BODY WASH

    NET CONTENTS: ONE GALLON (3.785 LITERS)

    TEA TREE FRONT PANEL

    TEA TREE BACK PANEL

  • 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:68878-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN2 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68878-120-202 in 1 CASE
    1NDC:68878-120-113.785 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/16/2004
    Labeler - Theochem Laboratories (004100038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Theochem Laboratories004100038manufacture(68878-120)
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