DALAN OCEAN BREEZE ANTIBACTERIAL DEODORANT- triclosan soap

dalan OCEAN BREEZE antibacterial deodorant by

Drug Labeling and Warnings

dalan OCEAN BREEZE antibacterial deodorant by is a Otc medication manufactured, distributed, or labeled by Dalan Kimya Endustri A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

dalan OCEAN BREEZE antibacterial soap deodorant soap

Active Ingredient / Purpose

Triclosan 0.1% ...... 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 develops 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, Sodium Chloride, Alkyl Lactate, Propylene Glycol, Potassium Iodide, Fucus Vesiculosus Extract, Titanium Dioxide, Etidronic Acid, Linalool, Limonene, Sodium Benzoate, Potassium Sorbate.

Representative Labeling

INGREDIENTS AND APPEARANCE

DALAN OCEAN BREEZE ANTIBACTERIAL DEODORANT 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51209-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETIDRONIC ACID (UNII: M2F465ROXU)
LINALOOL, (+)- (UNII: F4VNO44C09)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51209-003-00	3 in 1 BOX
1		90 g in 1 PACKAGE
2	NDC: 51209-003-01	3 in 1 BOX
2		125 g in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/06/2014

Labeler - Dalan Kimya Endustri A.S. (566219285)

Establishment
Name	Address	ID/FEI	Business Operations
Dalan Kimya Endustri A.S.		566219285	manufacture(51209-003)