ALCOHOL- 73938-2020 liquid 
Louisville Distilling 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 80% v/v

Antiseptic

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

• 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.

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

• 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.

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

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Label 2

ALCOHOL 
73938-2020 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73938-2020
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73938-2020-156780 mL in 1 DRUM; Type 0: Not a Combination Product03/24/2020
2NDC:73938-2020-2208190 mL in 1 DRUM; Type 0: Not a Combination Product03/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/24/2020
Labeler - Louisville Distilling Company, LLC (939097189)
Registrant - Louisville Distilling Company LLC, (939097189)
Establishment
NameAddressID/FEIBusiness Operations
Louisville Distilling Company, LLC939097189manufacture(73938-2020)

Revised: 3/2020
Document Id: a1b13b62-bb7b-849c-e053-2a95a90a2063
Set id: a188606e-38db-2a62-e053-2995a90a9565
Version: 2
Effective Time: 20200325
 
Louisville Distilling Company, LLC