ANTISEPTIC HAND SANITIZER EXTRA STRENGTH GEL- ethyl alcohol gel

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Commonwealth Homes, Inc., Integrity Specialty Products. 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 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

• on children less than 2 months of age
• on open 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 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 under 105°F

Inactive ingredients

Hydroxyethyl cellulose, Isopropyl myristate, Propylene glycol, Water

Questions?

1-937-848-2098

You can also report serious side effects to this phone number. Mon - Fri 9.00am - 5.00 pm

SPL UNCLASSIFIED SECTION

Manufactured by: Commonwealth Homes Inc, Centerville, Ohio, 45370

Made in the USA

Packaging

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER  EXTRA STRENGTH GEL
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73802-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L  in 1 L

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73802-101-01	3.79 L in 1 CONTAINER; Type 0: Not a Combination Product	03/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2020

Labeler - Commonwealth Homes, Inc. (127801525)

Establishment
Name	Address	ID/FEI	Business Operations
Commonwealth Homes, Inc.		127801525	manufacture(73802-101)