Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution

BALTIMORE SPIRITS CO HAND SANITIZER- alcohol liquid
Baltimore Whiskey Company 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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Ethanol 80%

Antiseptic

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

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

• in children less than 2 months of age

• on open skin wounds

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. If swallowed, get medical help or contact a Poison Control Center right away.

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 information

• Store between 15-30C (59-86F)

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

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

BALTIMORE SPIRITS CO HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73865-000
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

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

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

Labeler - Baltimore Whiskey Company LLC (086903343)

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