Iodine
FDA Label NDC 16638-166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Borisovskiy Zavod Medicinskikh Preparatov Jsc for the product Iodine (NDC 16638-166). 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, purpose, uses, warnings, otc - keep out of reach of children, directions, 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

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Purpose

Bactericidial - antiseptic

Uses

For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.

Directions

Apply to affected areas as needed or as directed by physician.

Other Information

Keep in a dark place at temperature below 25 oC.

Inactive Ingredients

Ethanol, Purified Water

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