FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
New Alchemy Distilling, LLC.
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:29

Label at a glance#

ProductHand 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1022 L NDC: 75019-001-00 1022 L Label1022 L Label

208 L NDC: 75019-001-01 208L label208L label

57 L NDC: 75019-001-02 57 L label57 L label

19 L NDC: 75019-001-03 19 L label19 L label

3.785 L NDC: 75019-001-04 3.785 L label3.785 L label

1.893 L NDC: 75019-001-05 1.893 L label1.893 L label

946 mL NDC: 75019-001-06 946 mL label946 mL label

473 mL NDC: 75019-001-07 473 mL label473 mL label

946 L NDC: 75019-001-08 946 mL pump label946 mL pump label

473 L NDC: 75019-001-09 473 mL pump label473 mL pump label

3.785 L NDC: 75019-001-04 New/Alternate NA 1 gal Hand Sanitizer LabelNew/Alternate NA 1 gal Hand Sanitizer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

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
75019-001-002021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-012021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-022021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-032021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-042021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-052021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-062021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer
75019-001-072021-07-23C16284748780-1c7ccaba7-10d7-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75019-001-00Hand Sanitizer1022 L in 1 CONTAINERLIQUID10222
75019-001-01Hand Sanitizer208 L in 1 DRUMLIQUID2082
75019-001-02Hand Sanitizer57 L in 1 DRUMLIQUID572
75019-001-03Hand Sanitizer19 L in 1 DRUMLIQUID192
75019-001-04Hand Sanitizer3.785 L in 1 JUGLIQUID3.7852
75019-001-05Hand Sanitizer1.893 L in 1 JUGLIQUID1.8932
75019-001-06Hand Sanitizer0.946 L in 1 BOTTLELIQUID0.9462
75019-001-07Hand Sanitizer0.473 L in 1 BOTTLELIQUID0.4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75019-001HAND SANITIZER (ALCOHOL) LIQUID [NEW ALCHEMY DISTILLING, LLC.]2Legacy NDC, 8 package rows20200609_a38cfe45-7a25-1d78-e053-2995a90ae8b9.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
75019-00175019-001-00, 75019-001-01, 75019-001-02, 75019-001-03, 75019-001-04, 75019-001-05, 75019-001-06, 75019-001-07

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
a75ca686-c3a3-5ac4-e053-2a95a90a2bdfa38cfe45-7a25-1d78-e053-2995a90ae8b92020-06-05WarningsExact identifier
spl id: a75ca686-c3a3-5ac4-e053-2a95a90a2bdf
spl set id: a38cfe45-7a25-1d78-e053-2995a90ae8b9

Reported adverse events (FAERS/openFDA)#

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