FDA Label for Proheal Povidone Iodine Prep Pads

View Indications, Usage & Precautions

Proheal Povidone Iodine Prep Pads Product Label

The following document was submitted to the FDA by the labeler of this product Click Industries Llc. 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.

Drug Facts




Active Ingredient



Povidone-Iodine 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 • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic for more than 1 week unless directed by a doctor

Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious wounds

Stop use and ask a doctor if • condition worsens or persists for more than 72 hours • irritation and redness develops 


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 


Directions



• for preparation of the skin prior to surgery, clean the affected area, remove the pad, apply to the operative site prior to surgery • 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


Inactive Ingredients



Citric Acid Monohydrate, Sodium Phosphate Dibasic, Water


Packaging




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