FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Alpha Aromatics
Effective date
2020-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:09:55

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

This is a hand sanitizer manufactured with:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (62%, 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(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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.
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.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55 gallons NDC: 75009-062-01

228079.07ml label228079.07ml label

275 gallons NDC: 75009-062-02

975671.57ml label975671.57ml label

5 gallons NDC: 75009-062-03

18920ml label18920ml label

1 gallon NDC: 75009-062-04

3780ml label3780ml label

1 quart NDC: 75009-062-05

946ml label946ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
247835ethanol 62 % Topical SolutionPSN2
247835ethanol 0.62 ML/ML Topical SolutionSCD2
247835ethanol 62 % Topical SolutionSY2
247835ethyl alcohol 62 % 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
75009-062-012022-01-28C16284748780-1d6a99b39-d8ba-a426-e053-dadaa90af4c2Hand Sanitizer 62%
75009-062-022022-01-28C16284748780-1d6a99b39-d8ba-a426-e053-dadaa90af4c2Hand Sanitizer 62%
75009-062-032022-01-28C16284748780-1d6a99b39-d8ba-a426-e053-dadaa90af4c2Hand Sanitizer 62%
75009-062-042022-01-28C16284748780-1d6a99b39-d8ba-a426-e053-dadaa90af4c2Hand Sanitizer 62%
75009-062-052022-01-28C16284748780-1d6a99b39-d8ba-a426-e053-dadaa90af4c2Hand Sanitizer 62%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75009-062-01Hand Sanitizer228079.07 mL in 1 DRUMLIQUID228079.072
75009-062-02Hand Sanitizer975671.57 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID975671.572
75009-062-03Hand Sanitizer18920 mL in 1 PAILLIQUID189202
75009-062-04Hand Sanitizer3780 mL in 1 JUGLIQUID37802
75009-062-05Hand Sanitizer946 mL in 1 BOTTLELIQUID9462

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75009-062HAND SANITIZER (ALCOHOL) LIQUID [ALPHA AROMATICS]2Legacy NDC, 5 package rows20200507_a409ffc9-282a-dc34-e053-2995a90a962e.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
75009-06275009-062-01, 75009-062-02, 75009-062-03, 75009-062-04, 75009-062-05

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 · Source PDF

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
a4fd951a-7ef3-12ef-e053-2a95a90a4d65a409ffc9-282a-dc34-e053-2995a90a962e2020-05-06WarningsExact identifier
spl id: a4fd951a-7ef3-12ef-e053-2a95a90a4d65
spl set id: a409ffc9-282a-dc34-e053-2995a90a962e

Reported adverse events (FAERS/openFDA)#

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