ANTISEPTIC HAND SANITIZER- ethyl alcohol spray 
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 Spray

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

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 Centre right away.

Directions

Other Information

Inactive ingredients

Water, Glycerol

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

ANTISEPTIC HAND SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65584-110
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65584-110-1259 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(65584-110)

Revised: 3/2020
Document Id: 16135c7c-d29f-4b05-a4e7-66cd38e7517c
Set id: 6df185ae-b850-4045-98a6-7426c384f0b8
Version: 1
Effective Time: 20200323
 
Higley Industries, Inc.