HAND SANITIZER- alcohol liquid 
Whiskey Acres Distilling Company

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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Hand sanitizer

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.

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

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:

Other Information:

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

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

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

4oz

16oz

32oz

64oz

128oz

640oz

2 oz10 oz270oz

55gal

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74148-111
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74148-111-02473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74148-111-01118.294 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74148-111-03946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:74148-111-041892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:74148-111-053785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:74148-111-0618927.1 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:74148-111-071022 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Whiskey Acres Distilling Company (075741260)
Establishment
NameAddressID/FEIBusiness Operations
Whiskey Acres Distilling Company075741260manufacture(74148-111)

Revised: 8/2020
Document Id: ac9e6cfd-1d80-a7ed-e053-2a95a90ab732
Set id: a1ec0b02-aee2-1740-e053-2995a90ab1b5
Version: 5
Effective Time: 20200811
 
Whiskey Acres Distilling Company