Onko Health
FDA Label NDC 77283-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Onko Pharmaceuticals Usa Inc for the product Onko Health (NDC 77283-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, directions, keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purposes

→ Uses

→ Warnings

→ Directions

→ Keep Out Of Reach Of Children

→ Other Information

→ Inactive Ingredients

→ Product Image

→ Product Image 236ml

→ Product Image 473ml

→ Package Label

→ Product Image 1000ml

Active Ingredients

Alcohol 80%

Purposes

Antiseptic.

Uses

· Helps reduce bacteria that potentially can cause disease.

· For use when soap and water are not available.

Warnings

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

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