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 Owens & Minor Distribution, 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.

Active Ingredient



Povidone-iodine USP 10%


Purpose



Antiseptic


Use



Antiseptic skin preparation


Warnings



For external use only


Do Not Use



• if allergic to iodine
• in the eyes


Ask A Doctor Before Use



if injuries are • deep or puncture wounds • serious burns


Stop Use And Ask A Doctor If



• infection occurs • redness, irritation, swelling or pain persists or increases  

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.


Keep Out Of Reach Of Children.



In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


Directions



Apply locally as needed


Other Information



• 1% titratable iodine • for hospital or professional use only


Inactive Ingredients



Purified water, Glycerin, Nonyl nonoxynol-10


Package Labeling:




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