FDA.reportPublic FDA data

International Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)

Manufacturer
INTERNATIONAL HARBOR LLC | Octapod, S.A. de C.V.
Effective date
2020-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:56

Label at a glance#

ProductInternational Harbor
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 75% 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

water, glycerin, carbomer, triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP 60 ml NDC:79838-003-01 PDP 60 mlPDP 60 ml

PDP 250 ml NDC:79838-003-02 PDP 250 mlPDP 250 ml

PDP 500 ml NDC:79838-003-03 PDP 500 mlPDP 500 ml

PDP 1000 ml NDC:79838-003-04 PDP 1000 mlPDP 1000 ml

PDP 1800 ml NDC:79838-003-05 PDP 1800 mlPDP 1800 ml

PDP 3785 ml NDC:79838-003-06 PDP 3785 mLPDP 3785 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79838-003-012021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-022021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-032021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-042021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-052021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-062021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79838-003-01International Harbor60 mL in 1 BOTTLEGEL601
79838-003-02International Harbor250 mL in 1 BOTTLEGEL2501
79838-003-03International Harbor500 mL in 1 BOTTLEGEL5001
79838-003-04International Harbor1000 mL in 1 BOTTLEGEL10001
79838-003-05International Harbor1800 mL in 1 BOTTLEGEL18001
79838-003-06International Harbor3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79838-003INTERNATIONAL HARBOR (ALCOHOL) GEL [INTERNATIONAL HARBOR LLC]1Legacy NDC, 6 package rows20200923_afdd2516-7405-c93c-e053-2995a90a8646.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
79838-00379838-003-01, 79838-003-02, 79838-003-03, 79838-003-04, 79838-003-05, 79838-003-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER 1342809Y72KV36IACT
WATER059QF0KO0RIACT
TRIETHANOLAMINE HYDRIODIDEDT98IT03JKIACT
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
afdd25ba-fe03-31e9-e053-2a95a90a2c99afdd2516-7405-c93c-e053-2995a90a86462020-09-21WarningsExact identifier
spl id: afdd25ba-fe03-31e9-e053-2a95a90a2c99
spl set id: afdd2516-7405-c93c-e053-2995a90a8646

Reported adverse events (FAERS/openFDA)#

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