Label: ANTIBACTERIAL CITRUS COCONUT- 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 24, 2010

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  • Active Ingredient

    Triclosan 0.3%

  • 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.

  • Uses

    For washing to decrease bacteria on the skin.

  • Directions

    Apply onto wet hands, work into a lather. Rinse thoroughly.

  • Inactive Ingredients

    Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamide DEA, Sodium Chloride, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, PEG-7 Glyceryl Cocoate, Cocos Nucifera (Coconut) Fruit Extract, Citrus Medica Limonum (Lemon) Extract, Tetrasodium EDTA, Sodium Styrene/PEG-10 Maleate/Nonoxynol-10 Maleate/ Acrylates Copolymer, Ammonium Nonoxynol-4 Sulfate, Citric Acid, Sodium Hydroxide, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Chromium Hydroxide Green ( CI 77289), Yellow 10 (CI 47005), Methylchloroisothiazolinone, Methylisothiazolinone.

  • PACKAGE FRONT AND BACK LABELS

    • 8.5 OZ Front Panel Label: eobf.jpg
      8.5OZ Front Panel Label
    • 8.5 OZ Back Panel Label: eobb.jpg
      8.5 OZ Back Panel Label
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  CITRUS COCONUT
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-287
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3000 mL  in 100.0000 mL
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-287-09251.00 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/24/2010
    Labeler - CVS Pharmacy (062312574)
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