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

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

A

BALTIMORE SPIRITS CO HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73865-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73865-000-003785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/23/2020
Labeler - Baltimore Whiskey Company LLC (086903343)
Establishment
NameAddressID/FEIBusiness Operations
Baltimore Whiskey Company LLC086903343manufacture(73865-000)

Revised: 4/2020
Document Id: a335c759-4781-36bd-e053-2995a90ab735
Set id: a14fd022-3165-0b47-e053-2995a90a11e4
Version: 2
Effective Time: 20200413
 
Baltimore Whiskey Company LLC