1. Home
  2. Labeler Index
  3. Humco Holding Group, Inc.
  4. 0395-9128
  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 GARGLE 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



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.


* Please review the disclaimer below.