HAND SANITIZER ANTICEPTIC- alcohol gel 
Aztex Enterprises

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.

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Hand Sanitizer

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.

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

Label Image 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL5 mL  in 8 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 1342 (UNII: 809Y72KV36)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon Fragrance) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75887-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
2NDC:75887-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
3NDC:75887-001-038 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/13/2011
4NDC:75887-001-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
5NDC:75887-001-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/13/2011
Labeler - Aztex Enterprises (253232326)
Registrant - Aztex Enterprises (253232326)
Establishment
NameAddressID/FEIBusiness Operations
Aztex Enterprises253232326manufacture(75887-001)

Revised: 12/2018
Document Id: 7d9025e5-ddd4-5e94-e053-2991aa0a439c
Set id: 46a655c9-0391-46c8-af77-d0a11bac9557
Version: 4
Effective Time: 20181221
 
Aztex Enterprises