Label: DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE REGENERATING- 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 February 12, 2016

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  • Active ingredients

    Triclosan 0.1%

  • Purpose

    Antibacterial

  • 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, C12-15 Alkyl Lactate, Propylene Glycol, Potassium Iodide, Fucus Vesiculosus Extract, Titanium Dioxide (CI 77891), Etidronic Acid, Tetrasodium EDTA, Disodium Distyrylbiphenyl Disulfonate, Linalool, Limonene, Sodium Benzoate, Potassium Sorbate.

  • Package Labeling:

    box label

  • INGREDIENTS AND APPEARANCE
    DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE REGENERATING 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51209-005-0090 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2015
    Labeler - Dalan Kimya Endustri A.S. (566219285)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalan Kimya Endustri A.S.566219285manufacture(51209-005)
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