FDA.reportPublic FDA data

GERMSTARORIGINAL

Manufacturer
Soaptronic, LLC
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
27
Source
full-release
Hydrated at
2026-06-01 00:53:41

Label at a glance#

ProductGERMSTARORIGINAL
Active ingredientISOPROPYL ALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Isopropyl alcohol 70% (W/W)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses


Kills 99.99% of all disease causing germs on contact, and protects and restores moisture.

WARNINGS SECTION

Warnings
For external use only. Keep out of eyes. In case of eye contact immediately flush eyes with water. If irritation persists, get medical attention. If swallowed, contact physician. Flammable, keep away from heat or flames. Germstar Wipes are safe for most surfaces, however can be harmful to some. Test wipe on a non-conspicuous area if unsure.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply Germstar all over the surface of your hands and rub into skin until dry. Supervise children in the use of this product.

SPL UNCLASSIFIED SECTION

Other information

Germstar is non allergenic. Store at 20° to 25°C (68° to 77°F). May be harmful to some surfaces/materials.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Emollient Complex, fragrance.

OTC - QUESTIONS SECTION

Questions?

Call Germstar at 1-800.327.2606

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Germstar OriginalGermstar Original

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN27
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD27
808520isopropyl alcohol 70 % Topical SolutionSY27

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-001-01GERMSTARORIGINAL946 g in 1 BAGSOLUTION94627
57915-001-02GERMSTARORIGINAL474 g in 1 BOTTLE, PUMPSOLUTION47427
57915-001-03GERMSTARORIGINAL236 g in 1 BOTTLE, SPRAYSOLUTION23627
57915-001-04GERMSTARORIGINAL59 g in 1 BOTTLE, SPRAYSOLUTION5927
57915-001-05GERMSTARORIGINAL8 g in 1 BOTTLE, SPRAYSOLUTION827
57915-001-06GERMSTARORIGINAL3780 g in 1 BOTTLESOLUTION378027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-001GERMSTARORIGINAL (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]27Current NDC, Legacy NDC, 6 package rows20250126_da3ac935-7dc7-4100-a702-959eb84077b2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M41630219
ISOPROPYL ALCOHOLACTIVE MOIETYND2M41630219
WATERINACTIVE INGREDIENT059QF0KO0R19

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57915-00157915-001-01, 57915-001-02, 57915-001-03, 57915-001-04, 57915-001-05, 57915-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
ndc (package): 57915-001-01
ndc (package): 57915-001-05
ndc (package): 57915-001-04
ndc (package): 57915-001-02
ndc (package): 57915-001-06
ndc (package): 57915-001-03
ndc (product): 57915-001
ndc11 (package): 57915000104
ndc11 (package): 57915000102
ndc11 (package): 57915000105
ndc11 (package): 57915000103
ndc11 (package): 57915000106
ndc11 (package): 57915000101
spl id: 2c797d11-a351-c63d-e063-6394a90a9376
spl set id: da3ac935-7dc7-4100-a702-959eb84077b2

Reported adverse events (FAERS/openFDA)#

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