DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE- triclosan soap 
Dalan Kimya Endustri A.S.

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.

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Dalan Antibacterial Deodorant Soap Ocean Breeze

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

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)

Revised: 2/2016
Document Id: 2b9b0d78-b289-59ef-e054-00144ff8d46c
Set id: 3777904a-abec-4208-99da-45c33550ad95
Version: 3
Effective Time: 20160212
 
Dalan Kimya Endustri A.S.