FDA.reportPublic FDA data

Onyx Advanced Hand Sanitizer

Manufacturer
ONYX PREMIERE LLC
Effective date
2020-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:22

Label at a glance#

ProductOnyx Advanced Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Dosage and administration

Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use:

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame. For external use only.

Do not 

OTC - DO NOT USE SECTION

ingest, if swallowed seek medical help. Avoid contact with eyes.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

Other information:

SPL UNCLASSIFIED SECTION

Store below 106°F (41°C).

May discolor certain fabrics or surfaces.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

demineralized water, glycerin, carbomer, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75403-000-012023-01-30C16284748780-1f386c64a-3373-0266-e053-dadaa90a7c1aOnyx Advanced Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75403-000-01Onyx Advanced Hand Sanitizer250 mL in 1 POUCHGEL2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75403-000ONYX ADVANCED HAND SANITIZER (ALCOHOL) GEL [ONYX PREMIERE LLC]1Legacy NDC, 1 package rows20200422_a3d73e4f-893e-6668-e053-2a95a90a6592.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75403-00075403-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
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
a3d7426f-58a0-0eed-e053-2995a90a03b0a3d73e4f-893e-6668-e053-2a95a90a65922020-04-21WarningsExact identifier
spl id: a3d7426f-58a0-0eed-e053-2995a90a03b0
spl set id: a3d73e4f-893e-6668-e053-2a95a90a6592

Reported adverse events (FAERS/openFDA)#

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