FDA.reportPublic FDA data

OnkoHealth Hand and surface sanitizer

Manufacturer
ONKO PHARMACEUTICALS USA INC. | CALDINI KIMYA SANAYI VE TICARET LIMITED SIRKETI | SEKTOR KIMYA DETERJAN SANAYI VE TICARET ANONIM SIRKETI
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:34:10

Label at a glance#

ProductOnkoHealth Hand and surface sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

Hand Sanitizer to help 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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help 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.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other information

STORAGE AND HANDLING 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 Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN4
1039339ethanol 0.8 ML/ML Topical SolutionSCD4
1039339ethanol 80 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77283-001-012022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-022022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-032022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-042022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-052022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-062022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-072022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-082022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b
77283-001-092022-01-28C16284748780-1d6a99b39-fff5-a426-e053-dadaa90af4c2c8094f06-eca1-4025-a7f5-a4ad28df403b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77283-001-01OnkoHealth Hand and surface sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1004
77283-001-02OnkoHealth Hand and surface sanitizer150 mL in 1 BOTTLE, PLASTICLIQUID1504
77283-001-03OnkoHealth Hand and surface sanitizer236 mL in 1 BOTTLE, PLASTICLIQUID2364
77283-001-04OnkoHealth Hand and surface sanitizer473 mL in 1 BOTTLE, PLASTICLIQUID4734
77283-001-05OnkoHealth Hand and surface sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10004
77283-001-06OnkoHealth Hand and surface sanitizer3790 mL in 1 BOTTLE, PLASTICLIQUID37904
77283-001-07OnkoHealth Hand and surface sanitizer10000 mL in 1 BOTTLE, PLASTICLIQUID100004
77283-001-08OnkoHealth Hand and surface sanitizer20000 mL in 1 BOTTLE, PLASTICLIQUID200004
77283-001-09OnkoHealth Hand and surface sanitizer355 mL in 1 BOTTLE, PLASTICLIQUID3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77283-001ONKOHEALTH HAND AND SURFACE SANITIZER (ALCOHOL) LIQUID [ONKO PHARMACEUTICALS USA INC.]4Legacy NDC, 9 package rows20201124_c8094f06-eca1-4025-a7f5-a4ad28df403b.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
77283-00177283-001-01, 77283-001-02, 77283-001-03, 77283-001-04, 77283-001-05, 77283-001-06, 77283-001-07, 77283-001-08, 77283-001-09

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
80665fc5-bfca-48b1-9a2a-54234028d3ffc8094f06-eca1-4025-a7f5-a4ad28df403b2020-11-20WarningsExact identifier
spl id: 80665fc5-bfca-48b1-9a2a-54234028d3ff
spl set id: c8094f06-eca1-4025-a7f5-a4ad28df403b

Reported adverse events (FAERS/openFDA)#

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