Halodine Oral Rinse
FDA Label NDC 78371-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Halodine Llc for the product Halodine Oral Rinse (NDC 78371-201). 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, uses, warnings, do not use, when using this product:, stop use and promptly ask your dentist or doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.75%

(0.175% Available Iodine)

Purpose

Antiseptic

Uses

  • Oral Antiseptic
  • First aid to help prevent infection in minor oral irritation caused by dental procedures

Do Not Use

  • If allergic to iodine
  • In the eyes
  • On children less than 3 years old
  • For more than 7 days unless directed by a dentist or doctor

Stop Use And Promptly Ask Your Dentist Or Doctor

if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Keep Out Of Reach Of Children.

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

Directions

For oral antisepsis in adults and children 3 years of age and older:

  • Twist off the narrow end of single ampoule.
  • Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
  • Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
  • Slightly lift chin and tilt head back to gargle, then spit out.

    • Children under 3 years of age: Consult a dentist or doctor

Other Information

  • Single use only; do not reuse
  • Not made with natural rubber latex
  • Store at room temperature; avoid excessive heat

Inactive Ingredients

hydroxyethylcellulose, purified water

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