PERSONAL CARE ANTIBACTERIAL- triclocarben soap

Personal Care Antibacterial by

Drug Labeling and Warnings

Personal Care Antibacterial by is a Otc medication manufactured, distributed, or labeled by Personal Care Products LLC, Ningbo Unichem Household Prodcuts Co Ltd, Shanghai Soap Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient               Purpose

Triclocarban .78%              Antibacterial

ASK DOCTOR

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose   Antibacterial

WHEN USING

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

STOP USE

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

DOSAGE & ADMINISTRATION

Directions

• Wet bar with water
• lather vigorously and wash skin
• rinse and dry thoroughly
  

INDICATIONS & USAGE

Uses for washing to decrease bacteria on the skin.

INACTIVE INGREDIENT

Inactive ingredients  sodium tallowate, sodium cocoate, sodium palm kernalate, sodium palmitate, cocnut acid, glycerin, sodium chloride, sorbitol, water(aqua), fragrance, titanium dioxide, BHT, disodium EDTA,

WARNINGS

warnings For external use only

PRINCIPAL DISPLAY PANEL

Personal Care

Antibacterial Soap

Long lasting Deodorant protection

2 bars

3 oz (86 g)ea (Total net wt 6 oz)

INGREDIENTS AND APPEARANCE

PERSONAL CARE ANTIBACTERIAL  
triclocarben soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	.67 g  in 86 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMITATE (UNII: JQ43KP6296)
COCONUT ACID (UNII: 40U37V505D)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9208-0	86 g in 1 BOX

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 Unichem Household Prodcuts Co Ltd		528196956	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Soap Co Ltd		545258233	manufacture