DEFNSE ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
Lusty Libation Ltd.

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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Def+nse 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 Center right away.

Directions

Other information

Inactive ingredients

denatonium benzoate, fragrance, glycerin, hydrogen peroxide, hydroxyethyl cellulose, water

Questions?

You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM

HOLISTIC LIVING

NPN: 80099248

Manufactured by: Lusty Libation Inc. 620 Supertest Rd., Unit 5, Toronto, ON, Canada M3J 2M5

Product of Canada.

www.holisticlivingltd.com

Packaging

untitled

Packaging

untitled

DEFNSE ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77846-888
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77846-888-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
2NDC:77846-888-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
3NDC:77846-888-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
4NDC:77846-888-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
5NDC:77846-888-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
6NDC:77846-888-404000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/26/2020
Labeler - Lusty Libation Ltd. (203992437)
Establishment
NameAddressID/FEIBusiness Operations
Lusty Libation Ltd.203992437manufacture(77846-888)

Revised: 7/2020
Document Id: 56629b5a-e4ac-4df6-b081-dd47dcd3c6c2
Set id: b310f394-9efb-46c5-ac47-10430aaa711b
Version: 1
Effective Time: 20200728
 
Lusty Libation Ltd.