ASSURED HAND SANITIZER 8OZ ALOE: Package Insert and Label Information

ASSURED HAND SANITIZER 8OZ ALOE- alcohol gel
Greenbrier International, 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.

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose
Antiseptic

Uses

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.

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

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

Directions

Other Information

Inactive Ingredients
water, propylene glycol, glycerin, carbomer, fragrance, triethanolamine, aloe barbadensis leaf juice, tocopheryl acetate, yellow 5, blue 1

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
MADE IN CHINA

236ml NDC: 33992-8951-1

236ml NDC: 33992-8951-1

front
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back
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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOMER 934
ALPHA-TOCOPHEROL ACETATE
TROLAMINE
ALOE VERA LEAF
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
Product Characteristics
Color green Score
Shape RECTANGLE Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33992-8951-1 236 mL in 1 BOTTLE None
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 Operations
LAB DOUCE BIOTECHNOLOGY HUIZHOU LTD 554425078 manufacture (33992-8951)

Revised: 04/2020 Greenbrier International, Inc.

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