FDA.reportPublic FDA data

germstarONE unscented

Manufacturer
Soaptronic, LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:48:30

Label at a glance#

ProductgermstarONE unscented
Active ingredientALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl alcohol 70% (V/V)

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, Isopropanol, Emollient Complex.

OTC - QUESTIONS SECTION

Questions?

Call Germstar at 1-949-465-8955

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Germstar ONE unscentedGermstar ONE unscented

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041807alcohol 63 % Topical SolutionPSN11
1041807ethanol 0.63 ML/ML Topical SolutionSCD11
1041807ethanol 63 % Topical SolutionSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57915-021-01germstarONE unscented946 g in 1 BAGSOLUTION94611
57915-021-02germstarONE unscented474 g in 1 BOTTLE, PUMPSOLUTION47411
57915-021-03germstarONE unscented236 g in 1 BOTTLE, SPRAYSOLUTION23611
57915-021-04germstarONE unscented59 g in 1 BOTTLE, SPRAYSOLUTION5911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57915-021GERMSTARONE UNSCENTED (ETHYL ALCOHOL) SOLUTION [SOAPTRONIC, LLC]11Current NDC, Legacy NDC, 4 package rows20241225_a6a798bd-09cb-1853-e053-2995a90a27f9.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
57915-02157915-021-01, 57915-021-02, 57915-021-03, 57915-021-04

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
germstarONE unscentedETHYL ALCOHOLSoaptronic, LLCa6a798bd-09cb-1853-e053-2995a90a27f92024-12-19WarningsExact identifier
ndc (package): 57915-021-03
ndc (package): 57915-021-04
ndc (package): 57915-021-02
ndc (package): 57915-021-01
ndc (product): 57915-021
ndc11 (package): 57915002103
ndc11 (package): 57915002102
ndc11 (package): 57915002101
ndc11 (package): 57915002104
spl id: 29a593b8-ff9f-bc5c-e063-6394a90a52cc
spl set id: a6a798bd-09cb-1853-e053-2995a90a27f9

Reported adverse events (FAERS/openFDA)#

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