SANITIZE 99.9% ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid

Sanitize 99.9% Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Sanitize 99.9% Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Radico Khaitan Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 80% v/v

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 yeas 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

glycerin, hydrogen peroxide, water

Questions?

+1-732-500-6268
You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

80% ALCOHOL STRENGTH

WHO recommended Formulation

CLEAN HANDS SAVE LIVES

MANUFACTURED BY: RADICO KHAITAN LTD., BAREILY ROAD, RAMPUR, U.P, INDIA-244901

MADE IN INDIA

EXPIRY DATE: 24 MONTHS FROM THE DATE OF MANUFACTURE

exports@radico.co.in

A product of India's largest spirits Distiller

Packaging

INGREDIENTS AND APPEARANCE

SANITIZE 99.9% ANTISEPTIC HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79390-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79390-999-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
2	NDC: 79390-999-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
3	NDC: 79390-999-20	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
4	NDC: 79390-999-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
5	NDC: 79390-999-51	5000 mL in 1 CAN; Type 0: Not a Combination Product	07/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020

Labeler - Radico Khaitan Limited (876772698)

Establishment
Name	Address	ID/FEI	Business Operations
Radico Khaitan Limited		876772698	manufacture(79390-999)