Otc - Active Ingredient
Active Ingredient
Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)
Povidone Iodine Prep Pad Swab
FDA Label NDC 34645-4008
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 Prep Pad (NDC 34645-4008). 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 - do not use, otc - stop use, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
First Aid Antiseptic
Indications & Usage
Use
First aid to help prevent infection in minor cuts, scraps, and burns
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not
use in the eyes
apply over large areas of the body
use on individuals who are allergic or sensitive to iodine
Otc - Stop Use
Stop use and consult a doctor
if the condition persists or gets worse
for use longer than 1 week
Otc - Ask Doctor
Ask a doctor
in case of deep or puncture wounds, animal bites, serious burns
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
Clean the affected area
Apply product on the area 1-3 time daily and discard
May be covered with a sterile bandage when dry
Inactive Ingredient
Inactive Ingredients
citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
Package Label.Principal Display Panel
Image of Pouch label
Pouch Label (Pouch)
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