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 skin

Warning

for extrenal 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 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 immediately

Direction

Wet hands
apply to hands
scrub thoroughly
rinse thoroughly

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

Visibly Clean Antibacterial Hand Soap

ANTIBACTERIAL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-202
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 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-202-25	739 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(50157-202)