Label: ANTIBACTERIAL- triclosan soap

  • Category: HUMAN OTC DRUG LABEL

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 July 23, 2010

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  • Active Ingredient

    Triclosan 0.115%

  • Purpose

    - Antibacterial.



  • Warnings

    For external use only.

    When using this product

    Avoid contact with eyes. If contact occurs, rinse with water.

    Stop using this product and ask doctor if

    Irritation or redness develops and lasts.

    Keep out of reach of children

    In case of accidental ingestions, get medical help or contact a Poison Control Center immediately.

  • Questions/Comments?

    1-800-934-1204

  • Directions

    Apply to wet hands, lather and rinse thoroughly.
  • Uses

    To help reduce bacteria on the skin

  • Inactive Ingredeints

    Water (Aqua), Sodium Laureth Sulfate, Lauramide DEA, Cocamidopropyl Betaine, Decyl Glucoside, Polyquaternium-7, Saccharomyces, Hydrolyzed Vegetable Protein, Camellia Sinensis (Green Tea) Leaf Extract, Sodium Bicarbonate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Niacinamide, Tetrasodium EDTA, Sodium Chloride, Fragrance (Parfum), DMDM Hydantoin, Citric Acid, Red 33 (CI 17200), Blue 1 (CI 42090).

  • Package Front and Back Labels

    bj1g.jpg1Gal Front and Back Labels

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL   WITH LIGHT MOISTURIZERS
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-141-503780 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/23/2010
    Labeler - BJWC (159082692)
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