Label: DALAN OCEAN BREEZE ANTIBACTERIAL DEODORANT- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 51209-003-00, 51209-003-01 - Packager: Dalan Kimya Endustri A.S.
- 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 2, 2015
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- Official Label (Printer Friendly)
- dalan OCEAN BREEZE antibacterial soap deodorant soap
- Active Ingredient / Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients:
- Representative Labeling
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INGREDIENTS AND APPEARANCE
DALAN OCEAN BREEZE ANTIBACTERIAL DEODORANT
triclosan soapProduct 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)