FDA.reportPublic FDA data

germstar Original unscented

Manufacturer
Soaptronic, LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:48:32

Label at a glance#

Productgermstar Original unscented
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.

OTC - QUESTIONS SECTION

Questions?

Call Germstar at 1-949-465-8955

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unscented 32ozUnscented 32ozUnscented 16ozUnscented 16ozUnscented 2ozUnscented 2oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN9
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD9
808520isopropyl alcohol 70 % Topical SolutionSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-004-01germstar Original unscented946 g in 1 BAGSOLUTION9469
57915-004-02germstar Original unscented474 g in 1 BOTTLE, PUMPSOLUTION4749
57915-004-03germstar Original unscented236 g in 1 BOTTLE, SPRAYSOLUTION2369
57915-004-04germstar Original unscented59 g in 1 BOTTLE, SPRAYSOLUTION599
57915-004-05germstar Original unscented8 g in 1 BOTTLE, SPRAYSOLUTION89

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-004GERMSTAR ORIGINAL UNSCENTED (ISOPROPYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]9Current NDC, Legacy NDC, 5 package rows20241225_da14d588-a9f7-4796-a532-20156afc100f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163024
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163024
WATERINACTIVE INGREDIENT059QF0KO0R4

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
57915-00457915-004-01, 57915-004-02, 57915-004-03, 57915-004-04, 57915-004-05

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
germstar Original unscentedISOPROPYL ALCOHOLSoaptronic, LLCda14d588-a9f7-4796-a532-20156afc100f2024-12-19WarningsExact identifier
ndc (package): 57915-004-04
ndc (package): 57915-004-03
ndc (package): 57915-004-01
ndc (package): 57915-004-02
ndc (package): 57915-004-05
ndc (product): 57915-004
ndc11 (package): 57915000403
ndc11 (package): 57915000402
ndc11 (package): 57915000404
ndc11 (package): 57915000401
ndc11 (package): 57915000405
spl id: 29a4c097-0c59-be6d-e063-6394a90a5d76
spl set id: da14d588-a9f7-4796-a532-20156afc100f

Reported adverse events (FAERS/openFDA)#

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