Label: WHITE TEA ANTIBACTERIAL 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 December 12, 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, Coconut Diethanolamide, Tetrasodium Salt of Ehylenediamine Tetraacetic Acid, Propylene Glycol, Aloe Extract, Citric Acid, FD&C Yellow # 5, Fragrance; 1, 2-benzisothiazolin-3-one and 2-methyl-4-isothiazolin-3-one

  • PRINCIPAL DISPLAY PANELWHITE TEA ANTIBACTERIALFOAMING HAND SOAPNET CONTENTS: 1250 ml

    WHITE TEA

  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    WHITE TEA ANTIBACTERIAL 
    white tea antibacterial soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68878-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.002 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68878-131-111250 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2008
    Labeler - Theochem Laboratories, Inc (004100038)
    Registrant - Theochem Laboratories, Inc (004100038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Theochem Laboratories Inc004100038manufacture(68878-131)
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