FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Otis Products, Inc.
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:17:03

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Use

INDICATIONS & USAGE SECTION

Use as hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soup and water are not available.

Warnings

WARNINGS SECTION

Warning 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 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.

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

Use

RECENT MAJOR CHANGES SECTION

Use as hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL NDC: 74473-486-01 1oz. HSAN1oz. HSAN

118.3 mL NDC: 74473-486-04 4oz. HSAN4oz. HSAN

236.58 mL NDC: 74473-486-08 8oz. HSAN8oz. HSAN

946.35 mL NDC: 74473-486-32 32oz. HSAN32oz. HSAN

3785.4 mL NDC: 74473-486-28 1 Gal. HSAN1 Gal. HSAN

1892.7 mL NDC: 74473-486-64 1/2 Gal. HSAN1/2 Gal. HSAN

208197.64 mL NDC: 74473-486-55 55 Gal. Drum HSAN55 Gal. Drum HSAN

118.3 mL NDC: 74473-486-98 4oz_SANITAC4oz_SANITAC

30 mL NDC: 74473-486-99 1oz SANITAC1oz SANITAC

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
74473-486-012022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-042022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-082022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-282022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-322022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-552022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-642022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-982022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer
74473-486-992022-01-28C16284748780-1d6a99b39-5a5c-a426-e053-dadaa90af4c280% Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74473-486-01Hand Sanitizer30 mL in 1 BOTTLE, SPRAYLIQUID302
74473-486-04Hand Sanitizer118.3 mL in 1 BOTTLE, PLASTICLIQUID118.32
74473-486-08Hand Sanitizer236.58 mL in 1 BOTTLE, SPRAYLIQUID236.582
74473-486-28Hand Sanitizer3785.4 mL in 1 BOTTLE, PLASTICLIQUID3785.42
74473-486-32Hand Sanitizer946.35 mL in 1 BOTTLE, PLASTICLIQUID946.352
74473-486-55Hand Sanitizer208197.64 mL in 1 DRUMLIQUID208197.642
74473-486-64Hand Sanitizer1892.7 mL in 1 BOTTLE, PLASTICLIQUID1892.72
74473-486-98Hand Sanitizer118.3 mL in 1 BOTTLE, PUMPLIQUID118.32
74473-486-99Hand Sanitizer30 mL in 1 BOTTLE, PUMPLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74473-486HAND SANITIZER (ETHYL ALCOHOL) LIQUID [OTIS PRODUCTS, INC.]2Legacy NDC, 9 package rows20200611_a59e878f-7ea1-7128-e053-2a95a90ac03b.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
74473-48674473-486-01, 74473-486-04, 74473-486-08, 74473-486-32, 74473-486-64, 74473-486-28, 74473-486-55, 74473-486-99, 74473-486-98

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
a720569d-a8ee-48aa-e053-2995a90a5394a59e878f-7ea1-7128-e053-2a95a90ac03b2020-06-02WarningsExact identifier
spl id: a720569d-a8ee-48aa-e053-2995a90a5394
spl set id: a59e878f-7ea1-7128-e053-2a95a90ac03b

Reported adverse events (FAERS/openFDA)#

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