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 Jianerkang Medical Co., Ltd. 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.

Otc - Active Ingredient



Active Ingredients

Povidone Iodine, USP 7.5% (0.75% available Iodine)


Otc - Purpose



Purpose

Antiseptic


Indications & Usage



Uses

For preparation of skin and mucous membranes prior to surgery


Warnings



Warnings

For external use only

Avoid use on persons allergic to iodine


Otc - Stop Use



Stop use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling


Otc - Keep Out Of Reach Of Children



Keep out of reach of children

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


Dosage & Administration



Directions

Patient preoperative prep

use full strength

apply solution saturated sponge to operative site

scrub in circular motion for 5 minutes starting at incision site and move outward

blot with sterile towel

follow with application of topical solution



Other Information



store at room temperature
avoid excessive heat (above104oF/40oC)
protect from freezing
latex free


Inactive Ingredient



Inactive Ingredients

alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide


Package Label




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