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 Mcl Enterprises. 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% (w/w) (equivalent to 1 % titratable iodine)


Purpose



Antiseptic


Use:



  • For preparation of the skin prior to surgery 
  • First aid antiseptic to help prevent infection in scrapes, minor cuts and burns

Warnings:



  • For external use only

Keep Out Of Reach Of Children.



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

Do Not Use:



  • in the eyes or apply over large areas of the body 
  • longer than 1 week unless directed by a doctor 
  • on individuals who are sensitive or allergic to iodine

Stop Use And Ask A Doctor If:



  • if irritation and redness develop. 
  • condition persists more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

Directions:



  • Clean the treatment area
  • Apply a small amout of this product on the area 1~3 times daily 
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Inactive Ingredient:



Purified Water


Package Labeling:




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