LE VITAL VANILLA HEAVEN- ethyl alcohol gel
Ningbo Liyuan Daily Chemical Products 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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Active ingredient

Ethyl Alcohol, 62%

Keep out of reach of children

In case of accidental ingestion, seek professional help or contact a Poison Control Center immediately

Purpose

Antiseptic

Uses

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

Warnings

For external use only - hands

Flammable. Keep away from heat and flame

Inactive ingredients

Water
Isopropyl alcohol
Glycerin
Carbomer
Amino methyl propanol
Parfum
Propylene Glycol
Isopropyl Myristate
Aloe Barbadensis Leaf Juice
Tocopheryl acetate

Directions

Wet hands thoroughly with product and rub until dry without wiping
Children under 6, use only with adult supervision

Vanilla Heaven Label

LE VITAL VANILLA HEAVEN
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76176-005
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76176-005-01	53 g in 1 PACKAGE; Type 0: Not a Combination Product	05/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/11/2016

Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(76176-005)