SAN-IT-E ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid

San-it-E Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

San-it-E Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Birko Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 71%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water 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 hour

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre 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

propylene glycol, water

Questions?

1-800-525-0476

You may also report serious side effects to this phone number Mon-Fri 9.00AM – 5.00PM

SPL UNCLASSIFIED SECTION

Manufactured by: Birko Corporation, 9152 Yosemite St., Henderson, CO 80640

Packaging

INGREDIENTS AND APPEARANCE

SAN-IT-E ANTISEPTIC HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66556-1946
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66556-1946-1	3780 mL in 1 JUG; Type 0: Not a Combination Product	03/26/2020
2	NDC: 66556-1946-6	189250 mL in 1 DRUM; Type 0: Not a Combination Product	03/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/26/2020

Labeler - Birko Corporation (007065360)

Establishment
Name	Address	ID/FEI	Business Operations
Birko Corporation		007065360	manufacture(66556-1946)