DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE REGENERATING- 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 regenerating

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

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)

Revised: 2/2016
Document Id: 2b9b0d78-b28f-59ef-e054-00144ff8d46c
Set id: 6008f241-fa11-451e-889a-691fd6c768b7
Version: 3
Effective Time: 20160212
 
Dalan Kimya Endustri A.S.