Povidone Iodine Liquid
FDA Label NDC 0395-9128

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Povidone Iodine (NDC 0395-9128). 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 other, active ingredient, purpose, use, warnings, stop use and consult a doctor if, when using this product do not, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Povidone-Iodine 0.5%

(0.05% available iodine)

Purpose

Antiseptic

Use

For the temporary relief of occasional sore throat.

Warnings

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

Stop Use And Consult A Doctor If

Symptoms do not improve in 7 days.

Irritation, pain or redness persists or worsens.

Swelling, rash or fever develops.

When Using This Product Do Not

Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor.

Swallow.

Use with hydrogen peroxide.

Keep Out Of Reach Of Children.

In case more than used for gargling is swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DO NOT SWALLOW

Adults and children 12 years and older:

  • Gargle with 10mL full strength for 30 seconds, then spit out.
  • Use only with dosing cup provided.
  • Use up to 4 times daily.

    • Children under 12:

    • Do not use.

Other Information

  • Store at 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F).
  • May stain clothing or dental work.
  • Avoid contact with jewelry, especially silver.

Inactive Ingredients

Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide.

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