ASSURED HAND SANITIZER WITH VITAMIN E- ethyl alcohol liquid 
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 62%

Purpose
Antiseptic

Uses • hand sanitizer to help reduce bacteria on the skin •recommended for repeated use.

Warnings •Flammable. • Keep away from fire and flame. •For external use only

When using this product •avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin.
Discontinue use if irritation develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children. Children should only use this product under adult supervision. Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other information • do not store above 105F. May discolor some fabrics. • Harmful to wood finishes and plastics

Directions • place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. • recommended for repeated use

Inactive ingredients carbomer, fragrance, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, tocopheryl acetate, water

Package Label
image of package label

ASSURED  HAND SANITIZER WITH VITAMIN E
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-4949
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-4949-8236 mL in 1 BOTTLE, PUMP
2NDC:33992-4949-1295 mL in 1 BOTTLE, PUMP
3NDC:33992-4949-2355 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/15/2012
Labeler - Greenbrier International Inc. (610322518)

Revised: 5/2012
Document Id: 196a6639-566d-4d98-b189-71a06df1a716
Set id: e1a4f279-ca20-4bfc-b05c-5a3415ad896a
Version: 1
Effective Time: 20120501
 
Greenbrier International Inc.