DEFNSE ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

Defnse Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Defnse Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Lusty Libation Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water

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
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

denatonium benzoate, fragrance, glycerin, hydrogen peroxide, hydroxyethyl cellulose, water

Questions?

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

HOLISTIC LIVING

NPN: 80099248

Manufactured by: Lusty Libation Inc. 620 Supertest Rd., Unit 5, Toronto, ON, Canada M3J 2M5

Product of Canada.

www.holisticlivingltd.com

Packaging

Packaging

INGREDIENTS AND APPEARANCE

DEFNSE ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77846-888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77846-888-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020
2	NDC: 77846-888-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020
3	NDC: 77846-888-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020
4	NDC: 77846-888-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020
5	NDC: 77846-888-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020
6	NDC: 77846-888-40	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/26/2020

Labeler - Lusty Libation Ltd. (203992437)

Establishment
Name	Address	ID/FEI	Business Operations
Lusty Libation Ltd.		203992437	manufacture(77846-888)