FDA.reportPublic FDA data

germstarLuxe

Manufacturer
Soaptronic, LLC
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:53:53

Label at a glance#

ProductgermstarLuxe
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl alcohol 63% (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.

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, Isopropanol, Emollient Complex, Fragrance

OTC - QUESTIONS SECTION

Questions?

Call Germstar at 1-800.327.2606

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Luxe boxLuxe box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041807alcohol 63 % Topical SolutionPSN7
1041807ethanol 0.63 ML/ML Topical SolutionSCD7
1041807ethanol 63 % Topical SolutionSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-007-01germstarLuxe8 g in 1 BOTTLE, SPRAYSOLUTION87
57915-007-02germstarLuxe8 g in 1 BOTTLE, SPRAYSOLUTION87
57915-007-03germstarLuxe8 g in 1 BOTTLE, SPRAYSOLUTION87
57915-007-10germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-11germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-12germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-13germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-14germstarLuxe15 g in 1 BOTTLE, SPRAYSOLUTION157
57915-007-15germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-16germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-17germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-18germstarLuxe118 g in 1 BOTTLESOLUTION1187
57915-007-19germstarLuxe118 g in 1 BOTTLESOLUTION1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-007GERMSTARLUXE (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]7Current NDC, Legacy NDC, 13 package rows20250130_471b466f-e3e5-3601-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57915-00757915-007-01, 57915-007-02, 57915-007-03, 57915-007-10, 57915-007-11, 57915-007-12, 57915-007-13, 57915-007-14, 57915-007-15, 57915-007-16, 57915-007-17, 57915-007-18, 57915-007-19

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
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
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
ndc (package): 57915-007-01
ndc (package): 57915-007-15
ndc (package): 57915-007-19
ndc (package): 57915-007-11
ndc (package): 57915-007-02
ndc (package): 57915-007-14
ndc (package): 57915-007-17
ndc (package): 57915-007-10
ndc (package): 57915-007-18
ndc (package): 57915-007-13
ndc (package): 57915-007-03
ndc (package): 57915-007-16
ndc (package): 57915-007-12
ndc (product): 57915-007
ndc11 (package): 57915000717
ndc11 (package): 57915000710
ndc11 (package): 57915000713
ndc11 (package): 57915000711
ndc11 (package): 57915000718
ndc11 (package): 57915000716
ndc11 (package): 57915000714
ndc11 (package): 57915000715
ndc11 (package): 57915000701
ndc11 (package): 57915000702
ndc11 (package): 57915000719
ndc11 (package): 57915000712
ndc11 (package): 57915000703
spl id: 2cd1af31-de7d-d32b-e063-6294a90a430b
spl set id: 471b466f-e3e5-3601-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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