DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE (TRICLOSAN) SOAP [DALAN KIMYA ENDUSTRI A.S.]

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DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE (TRICLOSAN) SOAP [DALAN KIMYA ENDUSTRI A.S.]
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NDC 51209-010-01
Set ID 3777904a-abec-4208-99da-45c33550ad95
Category HUMAN OTC DRUG LABEL
Packager Dalan Kimya Endustri A.S.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active ingredients

    Triclosan 0.1%

    Purpose

    Antibacterial Soap

  • Uses

    Antibacterial Soap

  • Warnings

    For external use only

    Do not use

    • this product on infants under 6 months of age.
    • in the eyes. If contact occurs, flush eyes with water.

    Stop use and ask a doctor if

    irritation and redness develop, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Lather over wet skin and rinse well.

  • Inactive ingredients:

    Sodium Tallowate, Sodium Palmate, Water (Aqua), Sodium Palm Kernelate, Fragrance (Parfum), Sodium Chloride, Titanium Dioxide (CI 77891), Tetrasodium EDTA, Etidronic Acid, Disodium Distyrylbiphenyl Disulfonate, C12-15 Alkyl Lactate, Butylene Glycol, Fucus Vesiculosus Extract, Lactice Acid, Sodium Benzoate, Potassium Sorbate, Linalool, Limonene, Geraniol, Citral.

  • Package Labeling

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    DISODIUM DISTYRYLBIPHENYL DISULFONATE (UNII: 81G7704MYR)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51209-010-013 in 1 BOX
    1115 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/05/2016
    Labeler - Dalan Kimya Endustri A.S. (566219285)
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