Hand Sanitizer

Manufacturer
Schnapsleiche LLC
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:31

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions Pump or pour as needed into your palms and thoroughly spread on both hands. Rub into skin until dry. .

Storage and handling

Warnings For external use only. Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit). Do not use in mouth, ears or eyes. In case of contact, flush eyes with water. Do not use on open wounds. Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours. Do not use on children less than 2 months of age. Children must be supervised ...

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

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethyl Alcohol 80% v/v

Schnapsleiche Hand SanitizerSchnapsleiche Hand Sanitizer

Purpose

OTC - PURPOSE SECTION

Antiseptic

PurposePurpose

Use

INDICATIONS & USAGE SECTION

For hand washing to help decrease bacteria on the skin when water, soap and towel are not available. Recommended for repeated use.

UseUse

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame. Do not store above 40 degress Celcius (105 degrees Farenheit).

WarningsWarnings

Do not use

OTC - DO NOT USE SECTION

Do not use in mouth, ears or eyes. In ase of contact, flush eyes with water.

Do not use on open wounds. DoNotUseDoNotUse

OTC - WHEN USING SECTION

Warnings
For external use only.
Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit).
Do not use in mouth, ears or eyes. In case of contact, flush eyes with water.
Do not use on open wounds.
Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours.
Do not use on children less than 2 months of age.
Children must be supervised in use of this WhenUsingWhenUsingproduct.

Stop Use

OTC - STOP USE SECTION

Warnings
For external use only.
Flammable. Keep away from heat and flame. Do
not store above 40 degrees Celcius (105 degrees
Farenheit).
Do not use in mouth, ears or eyes. In case of
contact, flush eyes with water.
Do not use on open wounds.
Stop use and seek a doctor if redness or irritation
develops and persist for more than 72 hours.
Do not use on children less than 2 months of age.

Children must be supervised in use of this product. StopUseStopUse

Child Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings
For external use only.
Flammable. Keep away from heat and flame. Do
not store above 40 degrees Celcius (105 degrees
Farenheit).
Do not use in mouth, ears or eyes. In case of
contact, flush eyes with water.
Do not use on open wounds.
Stop use and seek a doctor if redness or irritation
develops and persist for more than 72 hours.
Do not use on children less than 2 months of age.
Children must be supervised in use of this product. ChildWarningChildWarning

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
Pump or pour as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

. DirectionsDirections

Other information

STORAGE AND HANDLING SECTION

Warnings
For external use only.
Flammable. Keep away from heat and flame. Do not store above 40 degrees Celcius (105 degrees Farenheit).
Do not use in mouth, ears or eyes. In case of contact, flush eyes with water.
Do not use on open wounds.
Stop use and seek a doctor if redness or irritation develops and persist for more than 72 hours.
Do not use on children less than 2 months of age.
Children must be supervised in use of this product.

StorageHandlingStorageHandling

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Distilled Water, Hydrogen Peroxide, Glycerol,
Denatonium Benzoate

InactiveInactive

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

375 mL NDC: 74852-001-01

SCHNAPSLEICHE DISTILLERY

HAND SANITIZER

Manufactured in accordance with the FDA
Temporary Policy for Manufacture of Alcohol
for Incorporation Into Alcohol-Based Hand
Sanitizer Products During the Public Health
Emergency (COVID-19)

Volume 375ml

Manufactured by Schnapsleiche, LLC
Woodinville, WA
www.schnapsleichespirits.com

FrontLabel375mlFrontLabel375ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

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
74852-0001-12022-01-28C16284748780-1d6a99b39-efd2-a426-e053-dadaa90af4c2Hand Sanitizer
74852-0001-22022-01-28C16284748780-1d6a99b39-efd2-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74852-0001-1Hand Sanitizer375 mL in 1 BOTTLE, GLASSLIQUID3751
74852-0001-2Hand Sanitizer750 mL in 1 BOTTLE, GLASSLIQUID7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74852-0001HAND SANITIZER (ALCOHOL) LIQUID [SCHNAPSLEICHE LLC]1Legacy NDC, 2 package rows20200409_a2c111d0-18bf-f12d-e053-2a95a90aec7e.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
74852-000174852-0001-2, 74852-0001-1

Ingredients#

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

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

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
a2c0ede0-8123-89d3-e053-2995a90a0f8ea2c111d0-18bf-f12d-e053-2a95a90aec7e2020-04-08WarningsExact identifier
spl id: a2c0ede0-8123-89d3-e053-2995a90a0f8e
spl set id: a2c111d0-18bf-f12d-e053-2a95a90aec7e

Reported adverse events (FAERS/openFDA)#

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