ANTISEPTIC HAND SANITIZER- alcohol spray

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Canadian Liquids Processors Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

• in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Citric Acid, denatonium benzoate, FD&C yellow no.5, glycerin, hydrogen peroxide, propylene glycol, sodium benzoate, water.

Questions or Comments?

810-667-4885

Package Labeling:

Package Labeling:80691-001-02

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80691-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80691-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC: 80691-001-02	4000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2020

Labeler - Canadian Liquids Processors Limited (249855933)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Liquids Processors Limited		249855933	manufacture(80691-001)