The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Province Jianerkang Medical Dressing Co. ,ltd. for the product Povidone-iodine Prep Pad (NDC 34645-4002). 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 package label.principal display panel, otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Cat.40000-020 NDC 34645-4002-1 Qty. 1ea
Povidone-Iodine Prep Pad
Antiseptic/Germicide, Medium*For Single Use Only
Saturated with a 10% povidone-iodine solution
equivalent to 1% titratable iodine
For External Use Only
Distributed by:
Cardinal Health
Dublin, OH 43017 USA
Made in China
Image of Pouch Label
Pouch Label (Pouch)
Active ingredient
Povidone Iodine USP, 10% w/v
(equivalent to 1% titratable iodine)
Purpose
First Aid
Antiseptic
Use
First aid to help prevent infection in minor cuts, scrapes, and burns
Warnings
For external use only.
Do not * use in the eyes * apply over large areas of the body
* use on individuals who are allergic or sensitive to iodine
Stop use and consult a doctor
if the condition persists or gets worse
for use longer than 1 week
Ask doctor
in case of deep or puncture wounds, animal bites, serious burns.
Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
Clean the affected area
Apply product on the area 1-3 times daily and discard
May be covered with a sterile bandage when dry
Inactive ingredients
ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
* Please review the disclaimer below.
