FDA.reportPublic FDA data

Gabgerm Antiseptic Hand Sanitizer

Manufacturer
International Biotech Factory, S.A. de C.V.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:26

Label at a glance#

ProductGabgerm Antiseptic Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Indications and uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 72%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.
Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • In the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation and redness develop.
  • Condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

SPL UNCLASSIFIED SECTION

  • Keep at room temperature.
  • Avoid contact with skin accessories and wood.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Distilled water, fragrance, isopropyl myristate, lanolin, polyethylene glycol.

Package Labeling: Gabgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol, 60mL/2oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60mL60mL

Package Labeling: Gabgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol, 1000mL/33.8oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2393130isopropyl alcohol 72 % Topical SolutionPSN4
2393130isopropyl alcohol 0.72 ML/ML Topical SolutionSCD4
2393130isopropyl alcohol 72 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80284-001-012025-01-30C16284748780-12cef2736-7b7c-d83d-e063-dadaa90ab31fGabgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol
80284-001-022025-01-30C16284748780-12cef2736-7b7c-d83d-e063-dadaa90ab31fGabgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80284-001-01Gabgerm Antiseptic Hand Sanitizer60 mL in 1 BOTTLELIQUID604
80284-001-02Gabgerm Antiseptic Hand Sanitizer1 in 1 CARTONLIQUID14
80284-001-02Gabgerm Antiseptic Hand Sanitizer1000 mL in 1 BOTTLE, SPRAYLIQUID10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80284-001GABGERM ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [INTERNATIONAL BIOTECH FACTORY, S.A. DE C.V.]4Legacy NDC, 3 package rows20231222_c29de32c-be99-2b12-e053-2a95a90a06f6.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
80284-00180284-001-01, 80284-001-02

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
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
0d0b8e90-206b-1c76-e063-6394a90af668c29de32c-be99-2b12-e053-2a95a90a06f62023-12-21WarningsExact identifier
spl id: 0d0b8e90-206b-1c76-e063-6394a90af668
spl set id: c29de32c-be99-2b12-e053-2a95a90a06f6

Reported adverse events (FAERS/openFDA)#

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