Otc - Active Ingredient
Active Ingredients
Povidone Iodine, USP 7.5% (0.75% available Iodine)
Povidone Iodine Solution
FDA Label NDC 34645-4009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jianerkang Medical Co., Ltd for the product Povidone Iodine (NDC 34645-4009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Pouch Label (Pouch)
* Please review the disclaimer below.
