ANTIBACTERIAL- triclosan liquid
Brands International Corp

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 0.115%

Purpose - Antibacterial

Use for handwashing to decrease bacteria on the skin

Warning

For external use only - hands only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or redness develops and 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

Direction

wet hands
apply palmful to hands
scrub thoroughly
rinse thoroughly

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphoacetate, Polyquaternium 7, Glycerin, Citric Acid, Tocopheryl Acetate (Vit E Actetate), Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (Cl 17200), Blue 1 (42090)

Paris Antibacterial Hand Soap

ANTIBACTERIAL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.15 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-203-14	414 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/06/2016

Labeler - Brands International Corp (243748238)

Name	Address	ID/FEI	Business Operations
Establishment
Brands International Corp		243748238	manufacture(50157-203)