FRESH HAND SANITIZER- alcohol solution 
Speakeasy Spirits, 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.

----------

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

100 mL NDC: 74384-100-15

100 mL Label

250 mL NDC: 74384-100-15

250 mL Label

100 mL NDC: 74384-100-14

100 mL Label

118 mL NDC: 74384-100-12

Back Label 118 mL Bottle

118 mL NDC: 74384-100-12

Front Label 118 mL Bottle

4 mL NDC: 74384-100-11

Back Label 4 mL Bottle

4 mL NDC: 74384-100-11

Front Label 4 mL Bottle

750 mL NDC: 74384-100-10

Back Label 750 mL Bottle

750 mL NDC: 74384-100-10

Front Label 750 mL Bottle

1 L NDC: 74384-100-09

Back Label 1 L Bottle

1 L NDC: 74384-100-09

Front Label 1 L Bottle

3.785 L NDC: 74384-100-08

Back Label 3.785 L Pail

3.785 L NDC: 74384-100-08

Front Label 3.785 L Pail

18.93 L NDC: 74384-100-07

Back Label 18.93 L Pail

18.93 L NDC: 74384-100-07

Front Label 18.93 L Pail

50 mL NDC: 74384-100-06

Back Label 50 mL Bottle

50 mL NDC: 74384-100-06

Front Label 50 mL Bottle

750 mL NDC: 74384-100-05

Back Label 750 mL Bottle

750 mL NDC: 74384-100-05

Front Label 750 mL Bottle

1 L NDC 74384-100-04

Back Label 1 L Bottle

1 L NDC: 74384-100-04

Front Label 1 L Bottle

3.785 L NDC: 74384-100-03

Back Label 3.785 L Pail

3.875 L NDC: 74384-100-03

Front Label 3.785 L Pail

18.93 L NDC: 74384-100-02

Back Label 18.93 L Pail

18.93 L NDC:74384-100-02

Front Label 18.93 L Pail

1000 L NDC: 74384-100-01

Back Label 1000 L Tote

1000 L NDC: 74384-100-01

Front Label 1000 L Tote

FRESH HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74384-100
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74384-100-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product03/30/2020
2NDC:74384-100-0218927 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
3NDC:74384-100-033785 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
4NDC:74384-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:74384-100-05750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:74384-100-0650 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:74384-100-0718927 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
8NDC:74384-100-083785 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
9NDC:74384-100-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:74384-100-10750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
11NDC:74384-100-114 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
12NDC:74384-100-12118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
13NDC:74384-100-13118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2020
14NDC:74384-100-15250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
15NDC:74384-100-16100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Speakeasy Spirits, LLC (036373552)
Establishment
NameAddressID/FEIBusiness Operations
Speakeasy Spirits, LLC036373552manufacture(74384-100)

Revised: 7/2020
Document Id: a97eb02d-d363-55c9-e053-2a95a90a87d7
Set id: a22cb3a5-4afc-2f62-e053-2995a90a571b
Version: 6
Effective Time: 20200702
 
Speakeasy Spirits, LLC