BODY LUXURIES VANILLA FROSTING ANTIBACTERIAL HAND SANITIZER- alcohol liquid

body luxuries Vanilla Frosting Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

body luxuries Vanilla Frosting Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Enchante Accessories, Inc., Zhejiang Blue Dream Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Antibacterial Hand Sanitizer

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

Ethyl Alcohol 62%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• To decrease bacteria on the skin that could cause disease.
• Recommended for repeated use.

WARNINGS

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.
  

Stop use and ask a doctor if skin irritation develops.

Keep out reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

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 degrees F
• May discolor some fabrics.
  
• Harmful to wood finishes and plastics.
  

INACTIVE INGREDIENT

Inactive ingredients

Water (Aqua), Glycerin, Triethanolamine, Carbomer, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil,  FD and C Red No.40, FD and C Yellow 5, FD and C Blue No.1

SPL UNCLASSIFIED SECTION

Formulated Exclusively and Distributed By:

Enchante Accessories, Inc.,

New York, NYm 10016

Not Tested On Animals, For Adult Use Only.

Designed in the USA. Made in China

3 FL. OZ / 90ML

PRINCIPAL DISPLAY PANEL

body luxuries

Vanilla Frosting

Antibacterial Hand Sanitizer

3.1 FL. OZ / 90ML

INGREDIENTS AND APPEARANCE

BODY LUXURIES VANILLA FROSTING ANTIBACTERIAL HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-500
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
DMDM HYDANTOIN (UNII: BYR0546TOW)
JOJOBA OIL (UNII: 724GKU717M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-500-01	90 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	01/20/2010

Labeler - Enchante Accessories, Inc. (186050696)

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