ANTISEPTIC HAND SANITIZER EXTRA STRENGTH GEL- ethyl alcohol gel 
Commonwealth Homes, 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 70%

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

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

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

Made in the USA

Packaging

image description

ANTISEPTIC HAND SANITIZER  EXTRA STRENGTH GEL
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73802-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73802-101-013.79 L in 1 CONTAINER; Type 0: Not a Combination Product03/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2020
Labeler - Commonwealth Homes, Inc. (127801525)
Establishment
NameAddressID/FEIBusiness Operations
Commonwealth Homes, Inc.127801525manufacture(73802-101)
Establishment
NameAddressID/FEIBusiness Operations
Integrity Specialty Products608975228manufacture(73802-101)

Revised: 6/2020
Document Id: ff803aa9-f3ef-49f4-b67f-38a3bacaaa96
Set id: 4bf2a772-b554-4e5e-9fc0-ff9305e166a5
Version: 2
Effective Time: 20200615
 
Commonwealth Homes, Inc.