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

Warnings

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 n 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

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse thoroughly

Inactive Ingredients - Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphoacetate, Polyquaternium 7, Glycerin, Citric Acid, Aloe Barbadensis Leaf Extract, Tocopheryl (Vitamin E) Acetate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Red 4 (Cl 14700)

Visibly Clean Antibacterial Hand Soap Refill

ANTIBACTERIAL
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50157-201
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
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50157-201-24	709 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(50157-201)