Povidone-iodine Solution
FDA Label NDC 53329-938

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Povidone-iodine (NDC 53329-938). 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, uses, warnings, do not use, when using this product, stop use and ask 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

Active Ingredient

Povidone-Iodine 7.5%
(equivalent to 0.75% available iodine)

Purpose

Antiseptic

Uses

  • for preparation of the skin prior to surgery
  • helps to reduce bacteria that potentially can cause skin infection
  • significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Do Not Use

  • in the eyes
  • if you are allergic to iodine or any of the other ingredients in the product

When Using This Product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient

Stop Use And Ask A Doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison control center right away.

Directions

Surgical hand scrub:

  • Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge.
  • Wet hands and forearms
  • Apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • Use a sterile scrub brush, if desired
  • Rinse and repeat scrub

    • Patient Pre-operative Skin Preparation:

    • Prior to surgery, wet skin with water
    • Apply scrub to the operative site
    • Scrub thoroughly for about 5 minutes
    • Rinse using sterile gauze or towel, or remove with 70 percent alcohol
    • Follow with application of Medline Prep solution and allow to dry

Other Information

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Citric Acid, Cocamide DEA, Disodium Phosphate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water


Principal Display Panel

NDC 53329-938-23

PVP Scrub Solution

Antiseptic

Povidone-Iodine 7.5%

Sudsing Skin Cleanser

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