Warm Vanilla Hand Sanitizer (Ethyl Alcohol) Gel [Greenbrier International, Inc.] -

WARM VANILLA HAND SANITIZER (ETHYL ALCOHOL) GEL [GREENBRIER INTERNATIONAL, INC.]
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NDC	33992-3004-1
Set ID	73b9d440-503a-48f6-921f-ddde3b618344
Category	HUMAN OTC DRUG LABEL
Packager	Greenbrier International, Inc.
Generic Name
Product Class
Product Number
Application Number	PART333E

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ACTIVE INGREDIENT

Active Ingredient Purpose

Ethyl Alcohol 62.0%...........................Antimicrobial
PURPOSE
Uses
- for handwashing to decrease the bacteria on the skin
- recommended for repeated use
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE
Other information
- store at 20oC to 25oC (68o to 77oF)
- may discolor certain fabrics
WARNINGS

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
DOSAGE & ADMINISTRATION
Directions
- wet hands thoroughly with product
- briskly rub hands together until dry
- supervise children under 6 years in the use of this product
INACTIVE INGREDIENT

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, fd&c yellow no.5, fd&c red no.33.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WARM VANILLA HAND SANITIZER
ethyl alcohol gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	147 mL in 237 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-3004-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/24/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/24/2013

Labeler - Greenbrier International, Inc. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(33992-3004)

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