Label: ANTI-BACTERIAL FOAMING- triclosan 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 August 12, 2011

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  • Active Ingredient

    Triclosan 0.1%

  • Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

  • When using this product

    • avoid the eyes and mucous membranes
    • in the case of eyes or mucous membrane contact; rinse area thoroughly with water
  • Stop use and ask a doctor if

    • condition worsens
    • redness or irritation develops
    • if condition persists for more than 3 days
  • Keep out of reach of children

    If swallowed contact a doctor or Poison Control Center immediately.

  • Directions

    • Wet hands, work into a lather. Rinse well
    • supervise children in the use of this product
    • in the case of eye contact, rinse eyes thoroughly with water
  • Other information

    • store below 105F
    • may discolor some fabrics
  • Inactive Ingredients

    Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Blue 1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water
  • Package Label

    Package Label
    image of package label



  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL FOAMING  
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOPHENONE (UNII: 701M4TTV9O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-011-08240 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2011
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture
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