FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Watershed Distillery LLC
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:10:56

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80%

Logo Label Hand SanitizerLogo Label Hand Sanitizer

OTC - DO NOT USE SECTION

Do not use:
In children less than 2 months of age
On open skin wounds

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.

OTC - PURPOSE SECTION

Use(s)
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

OTC - STOP USE SECTION

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

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

OTHER SAFETY INFORMATION

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

WARNINGS AND PRECAUTIONS SECTION

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

INSTRUCTIONS FOR USE SECTION

Directions:
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.

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

DOSAGE & ADMINISTRATION SECTION

Directions
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.

WARNINGS SECTION

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

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

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer
Non-Sterile Solution
Denatured Alcohol Antiseptic 80%
Topical Solution
______mL ________ BATCH

Logo Label April 2020Logo Label April 2020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

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
74008-0001-12021-07-23C16284748780-1c7ccaba7-1b7e-fd44-e053-dadaa90aa01ba1d9b31f-156e-a490-e053-2a95a90aafb3
74008-0001-22021-07-23C16284748780-1c7ccaba7-1b7e-fd44-e053-dadaa90aa01ba1d9b31f-156e-a490-e053-2a95a90aafb3
74008-0001-32021-07-23C16284748780-1c7ccaba7-1b7e-fd44-e053-dadaa90aa01ba1d9b31f-156e-a490-e053-2a95a90aafb3
74008-0001-42021-07-23C16284748780-1c7ccaba7-1b7e-fd44-e053-dadaa90aa01ba1d9b31f-156e-a490-e053-2a95a90aafb3
74008-0001-52021-07-23C16284748780-1c7ccaba7-1b7e-fd44-e053-dadaa90aa01ba1d9b31f-156e-a490-e053-2a95a90aafb3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74008-0001-1HAND SANITIZER473 mL in 1 BOTTLE, PUMPLIQUID4733
74008-0001-2HAND SANITIZER3785 mL in 1 JUGLIQUID37853
74008-0001-3HAND SANITIZER18927 mL in 1 PAILLIQUID189273
74008-0001-4HAND SANITIZER1022061 mL in 1 CONTAINERLIQUID10220613
74008-0001-5HAND SANITIZER237 mL in 1 BOTTLE, PUMPLIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74008-0001HAND SANITIZER (WATERSHED DISTILLERY HAND SANITIZER) LIQUID [WATERSHED DISTILLERY LLC]3Legacy NDC, 5 package rows20200513_a1d9b31f-156e-a490-e053-2a95a90aafb3.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74008-000174008-0001-1, 74008-0001-2, 74008-0001-3, 74008-0001-4, 74008-0001-5

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
ALCOHOL3K9958V90MACTIB
GLYCEROL FORMAL3L7GR2604EIACT
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

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
a578ad4d-3881-055d-e053-2995a90a985aa1d9b31f-156e-a490-e053-2a95a90aafb32020-05-12WarningsExact identifier
spl id: a578ad4d-3881-055d-e053-2995a90a985a
spl set id: a1d9b31f-156e-a490-e053-2a95a90aafb3

Reported adverse events (FAERS/openFDA)#

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