Label: THEOCHEM WHITE TEA HAND AND BODY WASH- white tea 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, 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 in 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, Coconut Diethanolamide, Tetrasodium Salt of Ethylenediamine Tetraacetic Acid, Propylene Glycol, Aloe Extract, Citric Acid, Fragrance; 1,2-benzisothiazolin-3-one and 2-methyl-4-isothiazolin-3-one.

  • PRINCIPAL DISPLAY PANEL WHITE TEA HAND & BODY WASH NET CONTENTS: ONE GALLON (3.785 LITERS) 

    White TeaFront

    White Tea Back

  • INGREDIENTS AND APPEARANCE
    THEOCHEM WHITE TEA HAND AND BODY WASH 
    white tea hand and body wash soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68878-130
    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:68878-130-103.785 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/10/2008
    Labeler - Theochem Laboratories Inc (004100038)
    Registrant - Theochem Laboratories Inc (004100038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Theochem Laboratories Inc004100038manufacture(68878-130)
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