ALCOHOL- 73938-2020 liquid

Alcohol by

Drug Labeling and Warnings

Alcohol by is a Otc medication manufactured, distributed, or labeled by Louisville Distilling Company, LLC, Louisville Distilling Company LLC,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 80% v/v

PURPOSE

Antiseptic

INDICATIONS & USAGE

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

DO NOT USE

in children less than 2 months of age
on open skin wounds

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

For external use only. Flammable. Keep away from heat or flame

DOSAGE & ADMINISTRATION

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL 
73938-2020 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73938-2020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73938-2020-1	56780 mL in 1 DRUM; Type 0: Not a Combination Product	03/24/2020
2	NDC: 73938-2020-2	208190 mL in 1 DRUM; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/24/2020

Labeler - Louisville Distilling Company, LLC (939097189)

Registrant - Louisville Distilling Company LLC, (939097189)

Establishment
Name	Address	ID/FEI	Business Operations
Louisville Distilling Company, LLC		939097189	manufacture(73938-2020)