Active Ingredient
Povidone-iodine USP 10%
Povidone-iodine Prep Solution
FDA Label NDC 39892-0809
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Povidone-iodine Prep (NDC 39892-0809). 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, stop use and ask a doctor if, 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
Antiseptic
Use
Antiseptic skin preparation
Warnings
For external use only
Do Not Use
• if allergic to iodine
• in the eyes
Ask A Doctor Before Use
if injuries are • deep or puncture wounds • serious burns
Stop Use And Ask A Doctor If
• infection occurs • redness, irritation, swelling or pain persists or increases
Avoid pooling beneath patient
Avoid excessive heat. Store at room temperature.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Directions
Apply locally as needed
Other Information
• 1% titratable iodine • for hospital or professional use only
Inactive Ingredients
Purified water, Glycerin, Nonyl nonoxynol-10
Package Labeling:
Label (Label)
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