FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Den-Mat Holdings, LLC
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:14:08

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

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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

148 mL148 mL148 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237mL 237mL237mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473mL473mL473mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.78L3.78L3.78L

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
59883-301-012022-01-28C16284748780-1d6a99b39-72f4-a426-e053-dadaa90af4c2a2e0cc41-7153-dc64-e053-2a95a90a5129
59883-301-052022-01-28C16284748780-1d6a99b39-72f4-a426-e053-dadaa90af4c2a2e0cc41-7153-dc64-e053-2a95a90a5129
59883-301-082022-01-28C16284748780-1d6a99b39-72f4-a426-e053-dadaa90af4c2a2e0cc41-7153-dc64-e053-2a95a90a5129
59883-301-162022-01-28C16284748780-1d6a99b39-72f4-a426-e053-dadaa90af4c2a2e0cc41-7153-dc64-e053-2a95a90a5129
59883-301-362022-01-28C16284748780-1d6a99b39-72f4-a426-e053-dadaa90af4c2a2e0cc41-7153-dc64-e053-2a95a90a5129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-301-01Hand Sanitizer3785 mL in 1 BOTTLE, PUMPLIQUID37852
59883-301-05Hand Sanitizer148 mL in 1 BOTTLE, DISPENSINGLIQUID1482
59883-301-08Hand Sanitizer237 mL in 1 BOTTLE, DISPENSINGLIQUID2372
59883-301-16Hand Sanitizer473 mL in 1 BOTTLE, DISPENSINGLIQUID4732
59883-301-36Hand Sanitizer106 mL in 1 BOTTLE, DISPENSINGLIQUID1062

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-301HAND SANITIZER (ALCOHOL) LIQUID [DEN-MAT HOLDINGS, LLC]2Legacy NDC, 5 package rows20200522_a2e0cc41-7153-dc64-e053-2a95a90a5129.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
59883-30159883-301-36, 59883-301-05, 59883-301-08, 59883-301-16, 59883-301-01

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
a5f13111-efae-4eb1-e053-2a95a90a1a89a2e0cc41-7153-dc64-e053-2a95a90a51292020-05-18WarningsExact identifier
spl id: a5f13111-efae-4eb1-e053-2a95a90a1a89
spl set id: a2e0cc41-7153-dc64-e053-2a95a90a5129

Reported adverse events (FAERS/openFDA)#

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