TRICLOSAN- triclosan soap
Dyad Medical Sourcing, LLC

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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Active Ingredient:

Triclosan 0.2%

Purpose:

Antibacterial

Use:

For hand washing to decrease bacteria on skin

Inactive Ingredients:

Sodium Cocoate, Palm Kernelate, Water, Glycerin, Sodium Chloride, Fragrance, Titanium Dioxide.

Warning:

For external use only. Do not use in eyes. Discontinue if redness or irritation develops.

Keep out of reach of children

Use only as directed

Principal Display Panel - Case Label

HCS

Lightly Scented
Deodorant Soap

Gentle Formula
Antibacterial

No. 1-1/2

NDC 53175-003-01

Principal Display Panel - Case Label

HCS

Lightly Scented
Deodorant Soap

Gentle Formula
Antibacterial

No. 3/4

NDC 53175-003-02

TRICLOSAN
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53175-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Sodium Cocoate (UNII: R1TQH25F4I)
Sodium Palmate (UNII: S0A6004K3Z)
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Sodium Chloride (UNII: 451W47IQ8X)
Titanium Dioxide (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53175-003-01	500 in 1 CASE	03/01/2016
1		42.5 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:53175-003-02	1000 in 1 CARTON	03/01/2016
2		21.3 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2016

Labeler - Dyad Medical Sourcing, LLC (078572603)