AROMAFIELDS PLUMERIA SCENTED ANTIBACTERIAL HAND WASH- triclosan liquid

Aromafields Plumeria Scented Antibacterial Hand Wash by

Drug Labeling and Warnings

Aromafields Plumeria Scented Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by Enchante Accessories, Zhejiang Blue Dream Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active Ingredients                        Purpose

Triclosan 0.025% ..........................Antibacterial

PURPOSE

Uses

For handwashing 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

Stop use and ask a doctor if irritation and redness develop

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away

DOSAGE & ADMINISTRATION

Directions

Wet hands
Apply palmful to hands
Scrub thoroughly
Rinse
For children under 6, use only under adult supervision

INACTIVE INGREDIENT

Inactive ingredients

Water (aqua), Ammonium Lauryl Sulfate, Ammonium chloride, Lauramide DEA, DMDM Hydantoin, fragrance, Citric Acid, Tertrasodium EDTA, FDandC Blue 1, FDandC Yello 5, FDandC Red 40.

SPL UNCLASSIFIED SECTION

Formulated exclusively and distributed by:
Enchante Accessories, Inc.
New York, NY 10016
Not Tested On Animals. For adult use only.
Designed in the USA
Made in China
16.9 fl.oz./500ml

PRINCIPAL DISPLAY PANEL

Cranberry Vanilla

scented

Antibacterial

Hand Sanitizer

3.1 fl. oz. / 90ml

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AROMAFIELDS PLUMERIA SCENTED ANTIBACTERIAL HAND WASH 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.025 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-400-01	500 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	07/07/2010

Labeler - Enchante Accessories (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Blue Dream Cosmetic Co., Ltd.		529047234	manufacture