Label: HILL COUNTRY 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 October 7, 2010

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  • Active Ingredient

    Triclosan 0.15%

  • 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 and work into a lather, rinse thoroughly.
  • Uses

    To help reduce bacteria on the skin

  • Inactive Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Ammonium Lauryl Sulfate, Decyl Glucoside, Cocamidopropyl Betaine, Glycerin, Sodium Chloride, PEG-18 Glyceryl Oleate/cocoate, Fragrance (Parfum), Cocamide MEA, DMDM Hydantoin, Tetrasodium EDTA, Citric Acid,Yellow 5 (CI 19140), Red 4 (CI 14700)

  • Package Front and Back Labels

    hce7.5.jpg7.5 OZ Front and Back Labels

  • INGREDIENTS AND APPEARANCE
    HILL COUNTRY ESSENTIALS  ANTIBACTERIAL
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-220-08222 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/07/2010
    Labeler - HEB (007924756)
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