HAND SANITIZER ANTICEPTIC- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aztex Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Uses

for handwashing to decrease bacteria on the skin.

WARNINGS

Warnings for external use only.

When using this product; Do not use in eyes.

Discontinue use if irritation and redness develop

INDICATIONS & USAGE

Directions

wet hand thoroughly with product

briskly rub hands together until dry

INACTIVE INGREDIENT

Inactive Ingredients

Deionized water

Glycerin

Propylen Glycol

Triethanolamine

Carbomer

Methyloaraben

Proplyparaben

Lemon Fragrance

ACTIVE INGREDIENT

Drug Fact 8ml/0.25 fl.oz. Made in Canada -> (L) 8295

Active ingredient Purpose

Ethyl alcohol 62% Antisepctic

DOSAGE & ADMINISTRATION

8ml/0.25 fl. oz.

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

Anticeptic Hand Sanitizer

AZX SPORT

Manufactured for

AZX SPORT

925 Century Drive

Burlington, ON L7L 5LB

INGREDIENTS AND APPEARANCE

HAND SANITIZER  ANTICEPTIC
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75887-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	5 mL  in 8 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	LEMON (Lemon Fragrance)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75887-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2011
2	NDC: 75887-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2011
3	NDC: 75887-001-03	8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/13/2011
4	NDC: 75887-001-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2011
5	NDC: 75887-001-05	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/13/2011

Labeler - Aztex Enterprises (253232326)

Registrant - Aztex Enterprises (253232326)

Establishment
Name	Address	ID/FEI	Business Operations
Aztex Enterprises		253232326	manufacture(75887-001)