FDA Label for Povidone Iodine Prep

View Indications, Usage & Precautions

Povidone Iodine Prep Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 Ingredient



Povidone Iodine 10%

(equivalent to 1% titratable iodine)



Purpose



Antiseptic/First Aid Antispetic



Uses



  • First aid to help prevent skin infection in minor cuts,scrapes, and burns
  • For preparation of the skin prior to skin surgery
  • Helps to reduce bacteria that can potentially cause skin infection

Warnings



For External Use Only.



Do Not Use



As a first aid antiseptic



  • Do not use in the eyes or apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
  • Stop use and consult a doctor if the condition persists or gets worse
  • Do not use longer than 1 week unless directed by a doctor

  • For preoperative patient skin preparation



    • Do not use in the eyes
    • Discontinue use if irritation and redness develop
    • If condition persists for more than 72 hours, consult a doctor


Keep Out Of Reach Of Children.



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


Directions:



Clean the affected area.



For preparation of skin prior to surgery

  • Apply product to the operative site prior to surgery
  • For first aid antiseptic

    • 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



  • Protect from freezing
  • Avoid excessive heat


Inactive Ingredients:



Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water



Principal Display Panel



Povidone-Iodine Prep Solution

Povidone-Iodine 10%

single use only

Cardinal Health

Net Wt. 0.75 fl oz (22.2 mL)

NDC 63517-132-01







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