Gel Sanitizer

Manufacturer
AAkron Rule Corporation
Effective date
2022-07-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:16

Label at a glance#

ProductGel Sanitizer
Active ingredientALCOHOL
Label structure8 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 in 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on skin.

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.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Carbomer, D&C Green #5, D&C Yellow #10, Water, Trolamine

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69394-004-012024-01-30C16284748780-11030e365-231e-111a-e063-dadaa90a10e234ece294-7ed7-42c3-a29f-9898c64a2509
69394-004-022024-01-30C16284748780-11030e365-231e-111a-e063-dadaa90a10e234ece294-7ed7-42c3-a29f-9898c64a2509

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69394-004-01Gel Sanitizer30 mL in 1 BOTTLE, PLASTICGEL302
69394-004-02Gel Sanitizer89 mL in 1 BOTTLE, PLASTICGEL892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69394-004GEL SANITIZER (ALCOHOL) GEL [AAKRON RULE CORPORATION]2Legacy NDC, 2 package rows20220727_34ece294-7ed7-42c3-a29f-9898c64a2509.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69394-00469394-004-01, 69394-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
e4b43c01-0a43-3fe8-e053-2a95a90a33cb34ece294-7ed7-42c3-a29f-9898c64a25092022-07-26WarningsExact identifier
spl id: e4b43c01-0a43-3fe8-e053-2a95a90a33cb
spl set id: 34ece294-7ed7-42c3-a29f-9898c64a2509

Reported adverse events (FAERS/openFDA)#

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