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 1201258 Ontario Inc. O/a Nanz Pharma. 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 5%
0.5% available iodine
Purpose:
Topical Antiseptic
Warnings:
For external use only. 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 ask a doctor if the condition persists or gets worse. Stop use and ask doctor if redness, irritation, swelling, or pain persists, and infection occurs. Do not use longer than 1 week unless directed by a doctor. Do not use if allergic to iodine, in the eyes. Avoid pooling beneath the 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:
Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.
Use:
Antiseptic skin preparation
Other Information
- not made with natural rubber latex
- for hospital and professional use only.
Inactive Ingredients:
InAnhydrous dibasic sodium phosphate, citric acid monohydrate, glycerin, polyethylene glycol 1500, nonoxynol-9, potassium iodate, water
Questions:
Nanz Pharma Inc., 575 Granite Court, Pickering, ON, L1W 3K1, Canada
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