Drug Fact

BODY LUXURIES FRENCH LAVENDER SCENTED WATERLESS ANTI BACTERIAL HAND GEL - alcohol liquid
ENCHANTE ACCESSORIES INC.

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 Ingredient

Ethyl Alcohol 63%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin

For external use only, hands. Flammable, keep away from heat and flame.

When using this product: Keep out of eyes. In case of contact with eyes, flush throughly with water.

Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children.

Directions

Rub a dime size drop into hands

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

lab label

BODY LUXURIES FRENCH LAVENDER SCENTED WATERLESS ANTI BACTERIAL HAND GEL
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50563-149
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	33.8 mL in 100 mL
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50563-149-01	90 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/09/2013

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Aidi Cosmetics Co., Ltd.		530876820	manufacture(50563-149)