Povidone Iodine Prep
FDA Label NDC 63517-132

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Povidone Iodine Prep (NDC 63517-132). 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, keep out of reach of children., directions:, other information, 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% titratable iodine)


Purpose

Antiseptic/First Aid Antispetic


Uses

  • First aid to help prevent skin infection in minor cuts,scrapes, and burns
  • For preparation of the skin prior to skin surgery
  • Helps to reduce bacteria that can potentially cause skin infection

Warnings

For External Use Only.


Do Not Use

As a first aid antiseptic



  • Do not use in the eyes or apply over large areas of the body
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
  • Stop use and consult a doctor if the condition persists or gets worse
  • Do not use longer than 1 week unless directed by a doctor

    • For preoperative patient skin preparation



    • Do not use in the eyes
    • Discontinue use if irritation and redness develop
    • If condition persists for more than 72 hours, consult a doctor

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 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 1-3 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


Principal Display Panel

Povidone-Iodine Prep Solution

Povidone-Iodine 10%

single use only

Cardinal Health

Net Wt. 0.75 fl oz (22.2 mL)

NDC 63517-132-01



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