ANTISEPTIC HAND SANITIZER GEL- ethyl alcohol gel

Antiseptic Hand Sanitizer Gel by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Higley Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 62%

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° (59-86°F)
super avoid freezing and excessive heat above 40°C (104°F)
do not reuse container. Dispose of properly

Inactive ingredients

Water, Glycerol, Ammonium acryloyldimethyltaurate, 2-carboxyethyl acrylate crosspolymer

Questions?

+1-800-535-5053

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

SPL UNCLASSIFIED SECTION

Since H 1923

Manufactured by: Higley Industries, Inc. 585 Huff St., Dubuque IA, 52003

WWW.HIGLEYINC.COM

Packaging

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65584-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
2-CARBOXYETHYL ACRYLATE (UNII: KM1E1216WR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65584-100-12	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/19/2020

Labeler - Higley Industries, Inc. (005467626)

Establishment
Name	Address	ID/FEI	Business Operations
Higley Industries, Inc.		005467626	manufacture(65584-100)