SANIGEL- ethyl alcohol gel

SaniGel by

Drug Labeling and Warnings

SaniGel 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°C (59-86°F)

avoid freezing and excessive heat above 40°C (104°F)

do not reuse container. Dispose of properly

INACTIVE INGREDIENT

Inactive ingredients 2-carboxyethyl acrylate crosspolymer, Acryloyldimethyltaurate, Ammonium, Glycerol, Water

SPL UNCLASSIFIED SECTION

MADE IN THE USA

NEED GEL?

SaniStationola.com

(504) 609-2255

MANUFACTURED BY:

HIGLEY INDUSTRIES, INC.

DUBUQUE, IA 52003

WWW.HIGLEYINC.COM

Packaging

INGREDIENTS AND APPEARANCE

SANIGEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65584-200
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
2-CARBOXYETHYL ACRYLATE (UNII: KM1E1216WR)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65584-200-10	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/16/2020

Labeler - Higley Industries, Inc. (005467626)

Establishment
Name	Address	ID/FEI	Business Operations
Higley Industries, Inc.		005467626	manufacture(65584-200)