FDA.reportPublic FDA data

Exgerm Antiseptic Hand Sanitizer

Manufacturer
International Biotech Factory, S.A. de C.V.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:14

Label at a glance#

ProductExgerm Antiseptic Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure10 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, fragance, isopropyl myristate, lanolin, polyethylene glycol.

Package Labeling:1000ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:500ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2393130isopropyl alcohol 72 % Topical SolutionPSN2
2393130isopropyl alcohol 0.72 ML/ML Topical SolutionSCD2
2393130isopropyl alcohol 72 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80284-000-012025-01-30C16284748780-12cef2736-75c5-d83d-e063-dadaa90ab31fExgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol
80284-000-022025-01-30C16284748780-12cef2736-75c5-d83d-e063-dadaa90ab31fExgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol
80284-000-032025-01-30C16284748780-12cef2736-75c5-d83d-e063-dadaa90ab31fExgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol
80284-000-042025-01-30C16284748780-12cef2736-75c5-d83d-e063-dadaa90ab31fExgerm Antiseptic Hand Sanitizer 72% Isopropyl Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80284-000-01Exgerm Antiseptic Hand Sanitizer60 mL in 1 BOTTLELIQUID602
80284-000-02Exgerm Antiseptic Hand Sanitizer250 mL in 1 BOTTLELIQUID2502
80284-000-03Exgerm Antiseptic Hand Sanitizer500 mL in 1 BOTTLELIQUID5002
80284-000-04Exgerm Antiseptic Hand Sanitizer1000 mL in 1 BOTTLELIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80284-000EXGERM ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [INTERNATIONAL BIOTECH FACTORY, S.A. DE C.V.]2Legacy NDC, 4 package rows20231221_addf6a21-5c0e-59e2-e053-2a95a90a7080.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
80284-00080284-000-04, 80284-000-03, 80284-000-02, 80284-000-01

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
0d0058f6-9c5e-20a4-e063-6394a90a68f1addf6a21-5c0e-59e2-e053-2a95a90a70802023-12-21WarningsExact identifier
spl id: 0d0058f6-9c5e-20a4-e063-6394a90a68f1
spl set id: addf6a21-5c0e-59e2-e053-2a95a90a7080

Reported adverse events (FAERS/openFDA)#

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