RASPBERRY VANILLA SCENTED WATERLESS HAND SANITIZER (ALCOHOL) GEL [ENCHANTE ACCESSORIES, INC]

RASPBERRY VANILLA SCENTED WATERLESS HAND SANITIZER (ALCOHOL) GEL [ENCHANTE ACCESSORIES, INC]
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NDC	50563-150-03, 50563-150-08
Set ID	c28fa961-ab21-4cc3-8555-2405b5ae887a
Category	HUMAN OTC DRUG LABEL
Packager	Enchante Accessories, Inc
Generic Name
Product Class
Product Number
Application Number	PART333

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ACTIVE INGREDIENT

Active Ingredients

Ethyl Alcohol 62 percent

Purpose

Antiseptic
PURPOSE

Uses

To decrease bacteria on the skin that could cause disease.

Recommended for repeated use.
WARNINGS

Warnings

For external use only-hands

Flammable, Keep away from heat and flame.
INDICATIONS & USAGE

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

Not recommended for infants.
STORAGE AND HANDLING

Other Information

Do not store above 105 fahrenheit.

May discolor some fabrics.

Harmful to wood finishes and plastics.
INACTIVE INGREDIENT

Inactive Ingredients

Ingredients: Alcohol, Water (Aqua), Triethanolamine, Carbomer, Fragrance (Parfum), PEG 40 Hydrogenated Castor Oil,

DMDM Hydatoin, Hydrogenated Joboja Oil, FD and C Red No. 33, FD and C Red No. 40.
DESCRIPTION

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.
PRINCIPAL DISPLAY PANEL

Healing Waters

Raspberry Vanilla

Scented

Waterless

Hand Sanitizer

8 FL. OZ 236 ML
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RASPBERRY VANILLA SCENTED WATERLESS HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-150
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 934 (UNII: Z135WT9208)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
JOJOBA OIL (UNII: 724GKU717M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-150-08	236 mL in 1 BOTTLE
2	NDC:50563-150-03	90 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	02/22/2010

Labeler - Enchante Accessories, Inc (186050696)

Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)

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

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