FDA.reportPublic FDA data

Alcohol Based Hand Sanitizer

Manufacturer
Seattle Sanitizer LLC
Effective date
2020-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:55

Label at a glance#

ProductAlcohol Based Hand Sanitizer
Active ingredientALCOHOL
Label structure9 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) Denatured Alcohol, Ethyl Alcohol 85% as determined by hydrometer.

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 85% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

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

• on children less than 2 months of age

• on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.
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)
  • Denatured Alcohol, Ethyl Alcohol 85% as determined by hydrometer.

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

HIGHEST POTENCY 85% ETHANOL

HAND SANITIZER FOR FASTER MORE COMPLETE SANITIZING OF HANDS AND OTHER SURFACES

Highly effective while easy on your skin

FDA APPROVED FORMULA

non sterile solution

MADE IN THE USA

MANUFACTURED BY SKYBOUND SPIRITS
IN SEATTLE WASHINGTON
945 ELLIOT AVE WEST
SEATTLE, WA 98119

WWW.SEATTLESANITIZER.COM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250174ethanol 85 % Topical SolutionPSN1
1250174ethanol 0.85 ML/ML Topical SolutionSCD1
1250174ethanol 85 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78539-001-022022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-042022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-082022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-162022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-322022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-642022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78539-001-02Alcohol Based Hand Sanitizer59.14 mL in 1 BOTTLESOLUTION59.141
78539-001-04Alcohol Based Hand Sanitizer118.29 mL in 1 BOTTLESOLUTION118.291
78539-001-08Alcohol Based Hand Sanitizer236.5 mL in 1 BOTTLESOLUTION236.51
78539-001-16Alcohol Based Hand Sanitizer473.17 mL in 1 BOTTLESOLUTION473.171
78539-001-32Alcohol Based Hand Sanitizer1890 mL in 1 BOTTLESOLUTION18901
78539-001-64Alcohol Based Hand Sanitizer3780 mL in 1 BOTTLESOLUTION37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78539-001ALCOHOL BASED HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [SEATTLE SANITIZER LLC]1Legacy NDC, 6 package rows20200729_02b88d6c-1c64-4bb0-be81-012ce07f23f1.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
78539-00178539-001-02, 78539-001-04, 78539-001-08, 78539-001-16, 78539-001-32, 78539-001-64

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
82b5e971-d089-474d-8ed5-3992e2821c1d02b88d6c-1c64-4bb0-be81-012ce07f23f12020-07-18WarningsExact identifier
spl id: 82b5e971-d089-474d-8ed5-3992e2821c1d
spl set id: 02b88d6c-1c64-4bb0-be81-012ce07f23f1

Reported adverse events (FAERS/openFDA)#

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