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  5. Label Information: Betadine Gargle

FDA Label for Betadine Gargle

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Gargle Product Label

The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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