Antibacterial by Topco Associates LLC / BBC Group Limited ANTIBACTERIAL liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, BBC Group Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Triclosan 0.14%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

• When using this product, avoid getting into eyes. If this happens, rinse thoroughly with water.

• Keep out of reach of children.
• If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet hands
• pump into hands
• lather vigorously
• rinse and dry thoroughly

Inactive Ingredients

Water, Cocoamidopropyl Betaine, Sodium Lauryl Ether Sulphate, Coconut Acid Diethanol Amide, PEG-40 Castor Oil, Sodium Chloride, Phenoxyethanol, Fragrance, Citric Acid, Ethylenediaminetetraacetic Acid Disodium Salt, PEG-600 Stearate, Red 4(C.I. 14700)

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT RD.
SKOKIE, IL 60077
MADE IN CHINA
© TOPCO JPC1106

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Floral Bottle Label

VALU TIME
antibacterial
Hand Soap
FLORAL
11.5 FL OZ (340mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Herbal Bottle Label

VALU TIME
antibacterial
Hand Soap
HERBAL
11.5 FL OZ (340mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Natural Bottle Label

VALU TIME
antibacterial
Hand Soap
NATURAL
11.5 FL OZ (340mL)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
antibacterial liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X)	triclosan	0.476 mL  in 340 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
sodium chloride (UNII: 451W47IQ8X)
phenoxyethanol (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-101-01	340 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2006

ANTIBACTERIAL 
antibacterial liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X)	triclosan	0.476 mL  in 340 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
sodium chloride (UNII: 451W47IQ8X)
phenoxyethanol (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-102-01	340 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2006

ANTIBACTERIAL 
antibacterial liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X)	triclosan	0.476 mL  in 340 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
sodium chloride (UNII: 451W47IQ8X)
phenoxyethanol (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-103-01	340 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2006

Labeler - Topco Associates LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
BBC Group Limited		421270060	MANUFACTURE