FDA.reportPublic FDA data

ONKO HEALTH DISINFECTANT SPRAY

Manufacturer
ONKO PHARMACEUTICALS USA INC
Effective date
2021-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:06

Label at a glance#

ProductONKO HEALTH
Active ingredientALCOHOL
Label structure13 sections

Indications and uses

· Helps reduce bacteria that potentially can cause disease. · For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80%

Purposes

OTC - PURPOSE SECTION

Antiseptic.

Uses

INDICATIONS & USAGE SECTION

· Helps reduce bacteria that potentially can cause disease.

· For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame
Do not use

  • In children less than 2 months of age
  • On open skin wounds
  • When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

SPL UNCLASSIFIED SECTION

  • Store between 15-30C (59-86F)

● Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, hydrogen peroxide, purified water USP

Product Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Image 236mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Image 473mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Image 1000mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN1
1241663ethanol 0.8 ML/ML Topical SpraySCD1
1241663ethanol 80 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77283-003-012022-07-29C16284748780-1e4f33bdf-aa58-d8a0-e053-dadaa90a6e4eONKO HEALTH DISINFECTANT SPRAY
77283-003-022022-07-29C16284748780-1e4f33bdf-aa58-d8a0-e053-dadaa90a6e4eONKO HEALTH DISINFECTANT SPRAY
77283-003-032022-07-29C16284748780-1e4f33bdf-aa58-d8a0-e053-dadaa90a6e4eONKO HEALTH DISINFECTANT SPRAY
77283-003-042022-07-29C16284748780-1e4f33bdf-aa58-d8a0-e053-dadaa90a6e4eONKO HEALTH DISINFECTANT SPRAY
77283-003-052022-07-29C16284748780-1e4f33bdf-aa58-d8a0-e053-dadaa90a6e4eONKO HEALTH DISINFECTANT SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77283-003-01ONKO HEALTH100 mL in 1 BOTTLELIQUID1001
77283-003-02ONKO HEALTH236 mL in 1 BOTTLELIQUID2361
77283-003-03ONKO HEALTH473 mL in 1 BOTTLELIQUID4731
77283-003-04ONKO HEALTH561 mL in 1 BOTTLELIQUID5611
77283-003-05ONKO HEALTH1000 mL in 1 BOTTLELIQUID10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77283-003ONKO HEALTH (ALCOHOL) LIQUID [ONKO PHARMACEUTICALS USA INC]1Legacy NDC, 5 package rows20210120_c4e1b0a5-e38b-4f63-abdc-5933c1d8e462.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77283-00377283-003-01, 77283-003-02, 77283-003-03, 77283-003-04, 77283-003-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
b94697fa-33f3-405b-e053-2a95a90a7d31c4e1b0a5-e38b-4f63-abdc-5933c1d8e4622021-01-19WarningsExact identifier
spl id: b94697fa-33f3-405b-e053-2a95a90a7d31
spl set id: c4e1b0a5-e38b-4f63-abdc-5933c1d8e462

Reported adverse events (FAERS/openFDA)#

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