Active Ingredient
Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)
Povidone-iodine Prep Pad Solution
FDA Label NDC 63517-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 200, Inc. for the product Povidone-iodine Prep Pad (NDC 63517-400). 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 active ingredient, purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and consult a doctor, 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
Purpose
First Aid Antiseptic
Use
•first aid to help prevent skin infection in minor cuts, scrapes, and burns
Warnings
For external use only. Allergy Alert: Do not apply to persons allergic to Iodine
Do Not Use
• in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor
Ask A Doctor Before Use If You Have
• deep or puncture wounds • animal bites • serious burns
Stop Use And Consult A Doctor
if the condition persists or gets worse
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 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 15°-30°C (59°-86°F)
Inactive Ingredients
(purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide
Package Labeling:
Packet Labeling:
Packet Label (Pad)
Box Labeling:
Box Label (Label)
Carton Labeling:
Carton Labeling (Label2)
* Please review the disclaimer below.
