Povidone-iodine
FDA Label NDC 53329-900

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, Inc. for the product Povidone-iodine (NDC 53329-900). 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, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone Iodine 10% (equivalent to 1% available iodine)

Purpose

First Aid Antiseptic

Uses

  • Healthcare antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do Not Use

  • in the eyes
  • longer than 1 week unless directed by a doctor
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body

Stop Use And Ask A Doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the affected area.

  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Questions

1-800-MEDLINE

Principal Display Panel - Swabstick Singles Pouch

Principal Display Panel (Swabstick Singles pouch)

Principal Display Panel (Swabstick Singles pouch)

NDC53329-945-09

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

latex free

For professional and hospital use.

Contents: 1 Swabstick

Principal Display Panel - Swabstick Singles Box

Principal Display Panel (Swabstick Singles box)

Principal Display Panel (Swabstick Singles box)

NDC: 53329-945-29

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Singles

MDS093901

Discard appropriately after single use.

Protect from Freezing. Avoid excessive heat. For external use only.

latex free

Contents: 50 Each

Principal Display Panel - Swabstick Triples Box

Principal Display Panel (Swabstick Triples box)

Principal Display Panel (Swabstick Triples box)

NDC 53329-946-75

Medline

Antiseptic

Povidone-Iodine, USP

Swabsticks, Triples

MDS093902

Discard appropriately after single use.

Protect from freezing. Avoid excessive heat. For external use only.

latex free

Contents: 25 Pouches

Principal Display Panel - Prep Pads, Medium Box

Principal Display Panel (Prep Pads, Medium box)

Principal Display Panel (Prep Pads, Medium box)

Medline

Antiseptic

Povidone Iodine Prep Pads, Medium

MDS093917

For hospital and professional use.

Contents: 100 Pads

Principal Display Panel - Prep Pad Bulk Case

Principal Display Panel (Prep Pad Bulk Case)

Principal Display Panel (Prep Pad Bulk Case)

Povidone Iodine

Prep PADS
Medium Bulk

MDS093918

Contents: 3,000 Each Per Case

Principal Display Panel - Prep Solution Bottle

Principal Display Panel (Prep Solution bottle)

Principal Display Panel (Prep Solution bottle)

NDC: 53329-939-13

MEDLINE

PVP Prep Solution

Topical Antiseptic
Povidone-Iodine 10%

MDS093940

latexfree

www.medline.com

Manufactured for: Medline Industries, Inc.

Mundelein, IL 60060 USA Made in USA

To Order Call: 1-800-MEDLINE

RB11CTR

2 FL OZ (59 mL)

Principal Display Panel - Prep Solution Label

Principal Display Panel (Prep Solution label)

Principal Display Panel (Prep Solution label)

N: 53329-900-55

Medline

Prep Solution

with

Spray Bottle

Topical Antiseptic

Microbicide

MDS093942

latex free

Do not reuse

2 FL OZ (59 mL)

Principal Display Panel (Prep Solution label)

Principal Display Panel (Prep Solution label)

NDC 53329-904-04

Medline

Prep Solution

with Spray Bottle

Povidone Iodine USP, 10% Topical Solution

MDS093934

Topical Antiseptic

4 FL Oz (118 ml)

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