Assured Hand Sanitizer with Aloe Vera

Dosage form: liquid
Ingredients: ALCOHOL 62mL in 100mL
Labeler: Greenbrier International Inc.
NDC Code: 33992-4948

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 aloe barbadensis gel, carbomer, fragrance, FD&C blue no. 1, FD&C yellow no.5, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, water

Package Label

ASSURED  HAND SANITIZER WITH ALOE VERA
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-4948
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
GLYCERIN 
ISOPROPYL ALCOHOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PROPYLENE GLYCOL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:33992-4948-8236 mL in 1 BOTTLE, PUMP
2NDC:33992-4948-1295 mL in 1 BOTTLE, PUMP
3NDC:33992-4948-2355 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: 05/2012
 
Greenbrier International Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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