ANTIBACTERIAL- triclosan soap

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Personal Care Products LLC, Ningbo Pulisi Daily Chemical Products, Ningbo United Group Co Ltd, Ningbo Unichem Household Products Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Triclosan 0.2%

PURPOSE

Purpose  antibacterial

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

for hand washing to decrease bacteria on the skin.

WARNINGS

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

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

DOSAGE & ADMINISTRATION

Directions

Pump into hands

Lather vigorously for at least 15 seconds

Rinse and dry thoroughly

INACTIVE INGREDIENT

Inactive ingredients

Water (aqua), sodium laureth sulfate, sodium chloride, coamide DEA, DMDM hydantoin, fragrance, citric acid, tetrasodium EDTA, yellow #5, red #40

PRINCIPAL DISPLAY PANEL

Kills 99% of germs

Antibacterial soap

Moisterizing hand soap

15 fl oz (444 ml)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL  
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	.888 mL  in 444 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-903-85	444 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2011

Labeler - Personal Care Products LLC (966155082)

Registrant - Personal Care Products LLC (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products		529047265	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo United Group Co Ltd		544900137	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Unichem Household Products Co Ltd		528196956	manufacture