ANTISEPTIC HAND SANITIZER GEL- ethyl alcohol gel 
Higley Industries, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antiseptic HAND SANITIZER gel

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

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

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

Directions

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

Since H 1923

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

WWW.HIGLEYINC.COM

Packaging

image description

ANTISEPTIC HAND SANITIZER GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65584-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
2-CARBOXYETHYL ACRYLATE (UNII: KM1E1216WR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65584-100-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/19/2020
Labeler - Higley Industries, Inc. (005467626)
Establishment
NameAddressID/FEIBusiness Operations
Higley Industries, Inc.005467626manufacture(65584-100)

Revised: 3/2020
Document Id: decb81b3-736f-4001-a185-3da010637c57
Set id: 2fa47aa7-3918-4af2-a598-230c14eaab9a
Version: 1
Effective Time: 20200323
 
Higley Industries, Inc.