Betadine Gargle Solution
FDA Label NDC 67618-181

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Betadine Gargle (NDC 67618-181). 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 drug facts, purpose, uses, warnings, do not use this product, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient

Povidone-iodine, 0.5% (0.05% available iodine)

Purpose

Antiseptic

Uses

  • For the temporary relief of occasional sore throat

Warnings

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

Do Not Use This Product

  • for more than 7 days unless directed by a dentist or doctor
  • if you are allergic to povidone-iodine or any other ingredients in this product
  • if you have any thyroid conditions

When Using This Product

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
  • do not swallow
  • do not use with hydrogen peroxide

Stop Use And Ask A Doctor If

  • symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Directions

DO NOT SWALLOW
Adults and children 12 years and older:

  • Gargle with 10 ml 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 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F)
  • may stain clothing or dental work
  • avoid contact with jewelry, especially silver

Inactive Ingredients

citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium hydroxide

Package Label.Principal Display Panel

Betadine Gargle Carton
NDC: 67618-181-08

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