FDA Label for Povidone Iodine

View Indications, Usage & Precautions

Povidone Iodine Product Label

The following document was submitted to the FDA by the labeler of this product Jianerkang Medical Co., Ltd. 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.

Active Ingredients



Povidone lodine USP 10% W/V (equivalent to 1% titratable iodine)


Purpose



Antiseptic


Uses



  • Health-care antiseptic for preparation of the skin prior to surgery.
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts,scrapes,and burns.

Warnings



For external use only.

  • Do not use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body use as a first aid antiseptic longer than 1 week unless directed by a doctor.
  • Discontinue use if irritation and redness develop. Consult a doctor in case of deep or puncture wounds animal bites serious burns.

Stop Use And Consult A Doctor



if the condition persists or gets worse.


Keep Out Of Reach Of Children



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


Directions



For preparation of the skin prior to surgery

  • clean the affected area
  • remove swab by stick
  • apply to the operative site prior to surgery. F
  • For use as a first aid antiseptic

    • clean the affected area
    • apply a small amount of this product on the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged,let dry first.

Other Information



store at room temperature: 15°-30°C(59°-86°F)


Inactive Ingredients



citric acid, distilled water, sodium hydroxide, glycerin nonylphenol ethoxylate


Package Label




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