Povidone Iodine Prep Solution Sterile Solution
FDA Label NDC 34645-0013

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 Solution Sterile (NDC 34645-0013). 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 drug facts, active ingredient, purpose, use, warnings, do not use, ask a doctor before use if injuries are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Povidone-iodine USP 10%

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 professinoal assistance or consult a poion 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:

Bottle (Bottle)

Bottle (Bottle)

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