UNDENATURED ALCOHOL- alcohol liquid 
The Andersons Marathon Holdings LLC

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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Ingredient for hand sanitizer

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Contains water

Use

For use in production of hand sanitizers (antiseptic hand rubs) only. Denaturing required during hand sanitizer production.

Warnings

Non-potable. Flammable. Keep away from heat or flame

For use in production of hand sanitizers only.

Non-potable. Keep out of reach of children

Package Label - Principal Display Panel

NDC: 00000-000-00 UNDENATURED Alcohol

UNDENATURED ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75128-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL19000 kg  in 20000 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1000 kg  in 20000 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75128-190-0120000 kg in 1 TANK; Type 0: Not a Combination Product03/30/2020
2NDC:75128-190-02900 kg in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - The Andersons Marathon Holdings LLC (117229363)
Registrant - The Andersons Marathon Holdings LLC (117229363)
Establishment
NameAddressID/FEIBusiness Operations
The Andersons Marathon Holdings LLC080689407api manufacture(75128-190)
Establishment
NameAddressID/FEIBusiness Operations
The Andersons Marathon Holdings LLC117230221manufacture(75128-190)
Establishment
NameAddressID/FEIBusiness Operations
The Andersons Marathon Holdings LLC117502480api manufacture(75128-190)
Establishment
NameAddressID/FEIBusiness Operations
The Andersons Marathon Holdings LLC117502501api manufacture(75128-190)

Revised: 4/2020
Document Id: a2de6858-c80a-5c8e-e053-2a95a90a8bdf
Set id: a2de68df-2ee9-1dd9-e053-2a95a90adc67
Version: 1
Effective Time: 20200409
 
The Andersons Marathon Holdings LLC