BALTIMORE SPIRITS CO HAND SANITIZER- alcohol liquid

Baltimore Spirits Co Hand Sanitizer by

Drug Labeling and Warnings

Baltimore Spirits Co Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Baltimore Whiskey Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 80%

PURPOSE

Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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

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.

DOSAGE & ADMINISTRATION

Directions

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

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Inactive ingredients denatonium benzoate, glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALTIMORE SPIRITS CO HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73865-000
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73865-000-00	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/23/2020

Labeler - Baltimore Whiskey Company LLC (086903343)

Establishment
Name	Address	ID/FEI	Business Operations
Baltimore Whiskey Company LLC		086903343	manufacture(73865-000)