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  5. Label Information: Povidone Iodine

FDA Label for Povidone Iodine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. STOP USE AND CONSULT A DOCTOR IF
    7. WHEN USING THIS PRODUCT DO NOT
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. DO NOT USE THIS PRODUCT
    13. IF PREGNANT OR BREAST-FEEDING
    14. PURDUE ORAL RINSE LABEL

Povidone Iodine Product Label

The following document was submitted to the FDA by the labeler of this product Humco Holding Group, 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.

Other



Drug Facts


Active Ingredient



Povidone-Iodine 0.5%

(0.05% available iodine)


Purpose



Oral Antiseptic


Use



For preparation of the oral mucosa prior to injection, dental surgery or tooth extraction.


Warnings



Do not use this product

  • for more than 7 days unless directed by a dentist of doctor
  • in children under 12 years of age 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

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 rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Use full strength.
  • Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
  • Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
  • With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.

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.


* Please review the disclaimer below.