ASSURED HAND SANITIZER 8OZ ALOE- ethyl alcohol gel

ASSURED HAND SANITIZER 8OZ ALOE by

Drug Labeling and Warnings

ASSURED HAND SANITIZER 8OZ ALOE by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., LAB DOUCE BIOTECHNOLOGY HUIZHOU LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 70% v/v

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 only.

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  irritation or redness develop.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• squeeze as needed into your palms 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, carbomer, fragrance, triethanolamine, aloe barbadensis leaf juice, tocopheryl acetate, yellow 5, blue 1

INDICATIONS & USAGE

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

236ml NDC:

33992-8951-1

236ml NDC: 33992-8951-1

INGREDIENTS AND APPEARANCE

ASSURED HAND SANITIZER 8OZ ALOE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-8951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER 934 (UNII: Z135WT9208)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8951-1	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/09/2020

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
LAB DOUCE BIOTECHNOLOGY HUIZHOU LTD		554425078	manufacture(33992-8951)