PACIFIC ANTI-BACTERIAL HAND CLEANSE PEACH ESSENCE- triclosan gel

Pacific Anti-bacterial Hand Cleanse Peach Essence by

Drug Labeling and Warnings

Pacific Anti-bacterial Hand Cleanse Peach Essence by is a Otc medication manufactured, distributed, or labeled by Filo America, Ningbo Pulisi Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

PURPOSE

Uses

for handwashing to eliminate bacteria and germs on the skin.

KEEP OUT OF REACH OF CHILDREN

Keep away from children, except of under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

WARNINGS

Warnings

For external use only.

When using this productl, avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.

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

DOSAGE & ADMINISTRATION

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

INACTIVE INGREDIENT

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PACIFIC ANTI-BACTERIAL HAND CLEANSE PEACH ESSENCE 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50438-103-01	500 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/08/2013

Labeler - Filo America (943873703)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.		529047265	manufacture(50438-103)