HAND SANITIZER 3PK- ethyl alcohol kit

HAND SANITIZER 3PK by

Drug Labeling and Warnings

HAND SANITIZER 3PK by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Lab Douce Cosmetics (Shenzhen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ANTI-BACTERIAL 3PK HAND SANITIZER

SWEET CANDY CENTED HAND SANITIZER

VANILLA SCENTED HAND SANITIZER

SWEET PEA SCENTED HAND SANITIZER

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

ETHYL ALCOHOL 62%

PURPOSE

Purpose

Antiseptic

USE IN SPECIFIC POPULATIONS

Uses

• hand sanitizer to help decrease bacteria on the skin
• recommended for repeat use

WARNINGS

Warnings

• For external use.
• Flammable.

• Keep away from fire or flame.

Do not apply around eyes. Do not use in ears and mouth.

When using this product avoid contact with eyes. If contact occurs, rinse thorougly with water.

ASK DOCTOR

Stop use and ask a doctor if redness or irritation develop.

Keep out of reach of children. Children must be supervised in use of this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Children must be supervised in use of this product.

DOSAGE & ADMINISTRATION

Directions

• rub pump as needed into your palm and thoroughly spread on both hands.
• Rub into skin until dry

Other Information

• store at 20 degrees - 25 degrees C (68 degrees to 77 degrees F)
• may discolor fabrics

INACTIVE INGREDIENT

Inactive Ingredients

water, propylene glycol, glycerin, fragrance, carbomer, triethanolamine, tocopheryl acetate, red 33, yellow 5, blue 1

INDICATIONS & USAGE

DISTRIBUTED BY:

GREENBRIAR INTERNATIONAL, INC.,































CHESAPEAKE, VA 23320































MADE IN CHINA

ANTI-BACTERIAL HAND SANITIZER 3 PACK (33992-8909-1)

SWEET CANDY SCENTED HAND SANITIZER (33992-8906-0)

VANILLA SCENTED HAND SANITIZER (33992-8907-0)

SWEET PEA SCENTED HAND SANITIZER (33992-8908-0)

Labels

INGREDIENTS AND APPEARANCE

HAND SANITIZER 3PK 
ethyl alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-8909

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8909-1	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	09/02/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	29.6 mL
Part 2	1 BOTTLE	29.6 mL
Part 3	1 BOTTLE	29.6 mL

Part 1 of 3

SWEET CANDY SCENTED HAND SANITIZER 
ethyl alcohol gel

Product Information
Item Code (Source)	NDC: 33992-8906
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 940 (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	purple	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8906-0	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/02/2018

Part 2 of 3

VANILLA SCENTED HAND SANITIZER 
ethyl alcohol gel

Product Information
Item Code (Source)	NDC: 33992-8907
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	yellow	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8907-0	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/02/2018

Part 3 of 3

SWEET PEA SCENTED HAND SANITIZER 
ethyl alcohol gel

Product Information
Item Code (Source)	NDC: 33992-8908
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 940 (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	pink	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8908-0	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/02/2018

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
Lab Douce Cosmetics (Shenzhen) Co., Ltd.		529303186	manufacture(33992-8906, 33992-8907, 33992-8908, 33992-8909)