FDA.reportPublic FDA data

Fresh Hand Sanitizer

Manufacturer
Speakeasy Spirits, LLC
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:19:55

Label at a glance#

ProductFresh Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 74384-100-15

100 mL Label100 mL Label

250 mL NDC: 74384-100-15

250 mL Label250 mL Label

100 mL NDC: 74384-100-14

100 mL Label100 mL Label

118 mL NDC: 74384-100-12

Back Label 118 mL BottleBack Label 118 mL Bottle

118 mL NDC: 74384-100-12

Front Label 118 mL BottleFront Label 118 mL Bottle

4 mL NDC: 74384-100-11

Back Label 4 mL BottleBack Label 4 mL Bottle

4 mL NDC: 74384-100-11

Front Label 4 mL BottleFront Label 4 mL Bottle

750 mL NDC: 74384-100-10

Back Label 750 mL BottleBack Label 750 mL Bottle

750 mL NDC: 74384-100-10

Front Label 750 mL BottleFront Label 750 mL Bottle

1 L NDC: 74384-100-09

Back Label 1 L BottleBack Label 1 L Bottle

1 L NDC: 74384-100-09

Front Label 1 L BottleFront Label 1 L Bottle

3.785 L NDC: 74384-100-08

Back Label 3.785 L PailBack Label 3.785 L Pail

3.785 L NDC: 74384-100-08

Front Label 3.785 L PailFront Label 3.785 L Pail

18.93 L NDC: 74384-100-07

Back Label 18.93 L PailBack Label 18.93 L Pail

18.93 L NDC: 74384-100-07

Front Label 18.93 L PailFront Label 18.93 L Pail

50 mL NDC: 74384-100-06

Back Label 50 mL BottleBack Label 50 mL Bottle

50 mL NDC: 74384-100-06

Front Label 50 mL BottleFront Label 50 mL Bottle

750 mL NDC: 74384-100-05

Back Label 750 mL BottleBack Label 750 mL Bottle

750 mL NDC: 74384-100-05

Front Label 750 mL BottleFront Label 750 mL Bottle

1 L NDC 74384-100-04

Back Label 1 L BottleBack Label 1 L Bottle

1 L NDC: 74384-100-04

Front Label 1 L BottleFront Label 1 L Bottle

3.785 L NDC: 74384-100-03

Back Label 3.785 L PailBack Label 3.785 L Pail

3.875 L NDC: 74384-100-03

Front Label 3.785 L PailFront Label 3.785 L Pail

18.93 L NDC: 74384-100-02

Back Label 18.93 L PailBack Label 18.93 L Pail

18.93 L NDC:74384-100-02

Front Label 18.93 L PailFront Label 18.93 L Pail

1000 L NDC: 74384-100-01

Back Label 1000 L ToteBack Label 1000 L Tote

1000 L NDC: 74384-100-01

Front Label 1000 L ToteFront Label 1000 L Tote

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN6
1039339ethanol 0.8 ML/ML Topical SolutionSCD6
1039339ethanol 80 % Topical SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74384-100-012022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-022022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-032022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-042022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-052022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-062022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-072022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-082022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-092022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-102022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-112022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-122022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-132022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-152022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b
74384-100-162022-01-28C16284748780-1d6a99b39-e91c-a426-e053-dadaa90af4c2a22cb3a5-4afc-2f62-e053-2995a90a571b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74384-100-01Fresh Hand Sanitizer1000000 mL in 1 CONTAINERSOLUTION10000006
74384-100-02Fresh Hand Sanitizer18927 mL in 1 PAILSOLUTION189276
74384-100-03Fresh Hand Sanitizer3785 mL in 1 PAILSOLUTION37856
74384-100-04Fresh Hand Sanitizer1000 mL in 1 BOTTLESOLUTION10006
74384-100-05Fresh Hand Sanitizer750 mL in 1 BOTTLESOLUTION7506
74384-100-06Fresh Hand Sanitizer50 mL in 1 BOTTLESOLUTION506
74384-100-07Fresh Hand Sanitizer18927 mL in 1 PAILSOLUTION189276
74384-100-08Fresh Hand Sanitizer3785 mL in 1 PAILSOLUTION37856
74384-100-09Fresh Hand Sanitizer1000 mL in 1 BOTTLESOLUTION10006
74384-100-10Fresh Hand Sanitizer750 mL in 1 BOTTLESOLUTION7506
74384-100-11Fresh Hand Sanitizer4 mL in 1 BOTTLE, DISPENSINGSOLUTION46
74384-100-12Fresh Hand Sanitizer118 mL in 1 BOTTLESOLUTION1186
74384-100-13Fresh Hand Sanitizer118 mL in 1 BOTTLESOLUTION1186
74384-100-15Fresh Hand Sanitizer250 mL in 1 BOTTLESOLUTION2506
74384-100-16Fresh Hand Sanitizer100 mL in 1 BOTTLESOLUTION1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74384-100FRESH HAND SANITIZER (ALCOHOL) SOLUTION [SPEAKEASY SPIRITS, LLC]6Legacy NDC, 15 package rows20200703_a22cb3a5-4afc-2f62-e053-2995a90a571b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74384-10074384-100-01, 74384-100-02, 74384-100-03, 74384-100-04, 74384-100-05, 74384-100-06, 74384-100-07, 74384-100-08, 74384-100-09, 74384-100-10, 74384-100-11, 74384-100-12, 74384-100-13, 74384-100-15, 74384-100-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a97eb02d-d363-55c9-e053-2a95a90a87d7a22cb3a5-4afc-2f62-e053-2995a90a571b2020-07-02WarningsExact identifier
spl id: a97eb02d-d363-55c9-e053-2a95a90a87d7
spl set id: a22cb3a5-4afc-2f62-e053-2995a90a571b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.