Label: DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE REGENERATING- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 51209-005-00 - 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 12, 2016
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
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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:
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INGREDIENTS AND APPEARANCE
DALAN ANTIBACTERIAL DEODORANT OCEAN BREEZE REGENERATING
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51209-005 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:51209-005-00 90 g in 1 BOX; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2015 Labeler - Dalan Kimya Endustri A.S. (566219285) Establishment Name Address ID/FEI Business Operations Dalan Kimya Endustri A.S. 566219285 manufacture(51209-005)