Assured Instant Hand Sanitizer Refill 11.2 oz

ASSURED INSTANT HAND SANITIZER REFILL 11.2OZ ANTIMICROBIAL- ethyl 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.

----------

Active Ingredient Purpose

Ethyl Alcohol 70.0% v/v..................... Antimicrobial

Antimicrobial

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

for handwashing to decrease bacteria on the skin
recommended for repeated use

Directions

wet hands thoroughly with product
briskly rub hands together until dry
supervise children under 6 years in the use of this product

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.

Inactive Ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Other Information

store at 20C to 25C (68F to 77F)
may discolor certain fabrics

label

ASSURED INSTANT HAND SANITIZER REFILL 11.2OZ ANTIMICROBIAL
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-3039
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-3039-0	331 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/03/2020

Labeler - Greenbrier International, Inc. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(33992-3039)