PIER 1 IMPORTS SWEET ORANGE ANTI-BACTERIAL HAND WASH N/A- anti-bacterial hand wash liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)
Available from:
Xiamen Anna Global Co., Ltd
INN (International Name):
TRICLOSAN
Composition:
TRICLOSAN 0.115 g in 100 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses     For hand washing to decrease bacteria on skin
Authorization status:
OTC monograph not final
Authorization number:
49981-013-01

PIER 1 IMPORTS SWEET ORANGE ANTI-BACTERIAL HAND WASH N/A- anti-bacterial

hand wash liquid

Xiamen Anna Global Co., Ltd

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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Drug Fact

Active ingredients Purpose

Triclosan 0.115% Antibacterial

Uses For hand washing to decrease bacteria on skin

Warnings

For external use only

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

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or

contact a Poison Control Center right away

Directions Wet hands. Apply small amount to hands. Scrub thoroughly. Rinse. For children

under 6, use only under adult supervision

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium

Chloride, Cocamide DEA, Fragrance (Parfum), DMDM Hydantoin, Citric acid, Disodium EDTA, FD

and C Red No. 33, FD and C Yellow No. 5

label

PIER 1 IMPORTS SWEET ORANGE ANTI-BACTERIAL HAND WASH N/A

anti-bacterial hand wash liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 9 8 1-0 13

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRICLO SAN (UNII: 4NM50 39 Y5X) (TRICLOSAN - UNII:4NM50 39 Y5X)

TRICLOSAN

0 .115 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

8 1.19 552 g in 10 0 g

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

10 g in 10 0 g

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

2.5 g in 10 0 g

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

2.5 g in 10 0 g

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

1.8 5 g in 10 0 g

1,3 -DIMETHYLO L-5,5-DIMETHYL-HYDANTO IN (UNII: BYR0 546 TOW)

0 .5 g in 10 0 g

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

0 .0 0 9 g in 10 0 g

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

0 .0 3 g in 10 0 g

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

0 .0 0 0 19 g in 10 0 g

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

ORANGE (Sweet Orange)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 9 8 1-0 13-0 1

30 0 g in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333

12/30 /20 0 9

Labeler -

Xiamen Anna Global Co., Ltd (527060704)

Registrant -

Xiamen Anna Global Co., Ltd (527060704)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Xiamen Anna Global Co., Ltd

Xiamen Anna Glo bal Co ., Ltd

5270 6 0 70 4

ma nufa c ture

Revised: 12/2009

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