Povidone Iodine Prep Solution
FDA Label NDC 60913-051

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Phoenix Healthcare Solutions, Llc for the product Povidone Iodine Prep (NDC 60913-051). 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, consult a doctor in case of, stop use and consult 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 USP 10% v/v

Purpose

Antiseptic

Uses

  • Health-care antiseptic 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 in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
  • use as a first aid antiseptic longer than 1 week unless directed by 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 Consult A Doctor

if the condition persists or gets worse.

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
  • apply a small amount of this product on the area

    • 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: 59o - 86oF (15o - 30oC)

Inactive Ingredients:

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Principal Display Panel

NDC 60913-051-01

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Povidone Iodine Swabsticks

10% Povidone Iodine, USP

For Professional and Hospital Use

Antispetic/ Germicide

50 Pouches Per Box

1 Swabstick Per Pouch

Label (01)

Label (01)

NDC 60913-051-03

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Povidone Iodine Swabsticks

10% Povidone Iodine, USP

For Professional and Hospital Use

Antispetic/ Germicide

25  Pouches Per Box

3  Swabsticks Per Pouch

Label (03)

Label (03)

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