Hand Sanitizer

Manufacturer
AAkron Rule Corporation
Effective date
2022-07-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:50:15

Label at a glance#

ProductHand 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(S)

INDICATIONS & USAGE SECTION

helps reduce bacteria that can cause disease when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product avoid mouth, eyes, and ears. In case of contact with eyes, flush 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 and call Poison Control.

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.

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

LabelLabel

Label 2Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN4
1039339ethanol 0.8 ML/ML Topical SolutionSCD4
1039339ethanol 80 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69394-001-01Hand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID304
69394-001-02Hand Sanitizer89 mL in 1 BOTTLE, PLASTICLIQUID894
69394-001-03Hand Sanitizer1893 mL in 1 BOTTLE, PLASTICLIQUID18934

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69394-001HAND SANITIZER (ALCOHOL) LIQUID [AAKRON RULE CORPORATION]4Legacy NDC, 3 package rows20220726_7ff1c2d4-3a11-4606-829e-0c8930d7c3e2.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
69394-00169394-001-01, 69394-001-02, 69394-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
e4a2adc1-fcf5-895a-e053-2a95a90ac09b7ff1c2d4-3a11-4606-829e-0c8930d7c3e22022-07-25WarningsExact identifier
spl id: e4a2adc1-fcf5-895a-e053-2a95a90ac09b
spl set id: 7ff1c2d4-3a11-4606-829e-0c8930d7c3e2

Reported adverse events (FAERS/openFDA)#

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