Povidone Iodine
FDA Label NDC 68345-863

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pss World Medical, Inc. for the product Povidone Iodine (NDC 68345-863). 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 consult 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 USP, 10% w/v

(equipvalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

  • Health-care antisptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Warnings

For external use only.

Do Not Use

Do not use or apply

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

Stop Use And Consult A Doctor

Discontinue use if irritation and redness develop.

Consult a doctor in case of

  • deep or puncture wounds
  • animal bites
  • serious burns

    • Stop use and cosult a doctor if the condition persists or gets worse.

Keep Out Of Reach Of Children

Keep out of reach of children.

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

Directions

For preparation of the skin prior to surgery

Clean the affected area, remove swab by stick, apply to the operative site prior to surgery.

For use as a first aid antiseptic

Clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Store at room temperature: 15-30C (59-86F)

Inactive Ingredients

Citrict Acid, Glycerin, Nonoxynol-8, Purified Water, Sodium Hydroxide

Questions

Questions about Select? 800-777-4908

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Made in China

Package Label

986 Each

9986 Box

68345-863-01

1 each/pouch

50 pouches/box

68345-863-03

3 each/pouch

25 pouches/box

PPovidone Iodine, USP Swabsticks

AAntiseptic Germicide Sterile

  • Topical pre-surgical and first aid antiseptic swabstick
  • For hospital and professional use only

    • Single use only. Sterile unless package is opened or damaged.

* Please review the disclaimer below.