Label: IMAGE ESSENTIALS ANTIBACTERIAL- 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 November 9, 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 ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply onto wet hands, work into a lather, rinse thoroughly.
  • Uses

    Helps reduce bacteria on the skin

  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamide MEA, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Decyl Polyglucose, Sodium Chloride, Fragrance (Parfum), DMDM Hydantoin, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Polyquaternium-7, PEG- 7 Glyceryl Cocoate, Red 33 (CI 17200), Blue 1 (CI 42090).

  • Package Front and Back Labels

    IE.jpgF-B LABELS

  • INGREDIENTS AND APPEARANCE
    IMAGE ESSENTIALS  ANTIBACTERIAL
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-720
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-720-401180 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/09/2010
    Labeler - KMART CORPORATION (008965873)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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