Active Ingredient
Povidone-Iodine USP 10%
Povidone-iodine Prep Sterile Sponge
FDA Label NDC 59050-658
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Changzhou Maokang Medical Products Co., Ltd for the product Povidone-iodine Prep Sterile (NDC 59050-658). 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, 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
- For preparation prior to surgery
- Helps to reduce bacteria that can potentially cause skin infection.
Warnings
For external use only.
Do not apply to persons allergic to iodine
Do Not Use
- in the eyes
Ask A Doctor Before Use If
injuries are • deep wounds
• puncture wounds • serious burns
Stop Use And Ask A Doctor If
• irritation and redness develop
• condition persists for more than 72 hours • infection occurs
Avoid pooling beneath the patient.Prolonged exposure to wet solution may cause skin irritation.
Keep Out Of Reach Of Children.
If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Directions
Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.
Other Information
• 1% titratable iodine • latex free • for hospital or professional use only
Inactive Ingredients
Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water
Package Labeling:
Label0 (Label0)
* Please review the disclaimer below.
