Hand Sanitizer Anticeptic

Dosage form: gel
Ingredients: ALCOHOL 5mL in 8mL
Labeler: Aztex Enterprises
NDC Code: 75887-001

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.

Flammable, keep away from fire or flames.
Keep out of reach of children
If swallowed contact a Poison Control Center right away
If pregnant or breast feeding, ask a health care professional before use

Uses
for handwashing to decrease bacteria on the skin.

Warnings for external use only.
When using this product; Do not use in eyes.
Discontinue use if irritation and redness develop

Directions
wet hand thoroughly with product
briskly rub hands together until dry

Inactive Ingredients
Deionized water
Glycerin
Propylen Glycol
Triethanolamine
Carbomer
Methyloaraben
Proplyparaben
Lemon Fragrance

Drug Fact 8ml/0.25 fl.oz. Made in Canada -> (L) 8295
Active ingredient Purpose
Ethyl alcohol 62% Antisepctic

8ml/0.25 fl. oz.

Anticeptic Hand Sanitizer
AZX SPORT
Manufactured for
AZX SPORT
925 Century Drive
Burlington, ON L7L 5LB
HAND SANITIZER  ANTICEPTIC
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75887-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (SACCHARIN) ALCOHOL5 mL  in 8 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
TROLAMINE 
CARBOMER 1342 
METHYLPARABEN 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon Fragrance) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:75887-001-0130 mL in 1 BOTTLE
2NDC:75887-001-0260 mL in 1 BOTTLE
3NDC:75887-001-038 mL in 1 BOTTLE, SPRAY
4NDC:75887-001-04118 mL in 1 BOTTLE
5NDC:75887-001-05236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/18/2011
Labeler - Aztex Enterprises (253232326)
Registrant - Aztex Enterprises (253232326)
Establishment
NameAddressID/FEIOperations
Aztex Enterprises253232326manufacture

Revised: 01/2011
 
Aztex Enterprises

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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