Povidone Iodine Prep
FDA Label NDC 71622-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mcl Enterprises for the product Povidone Iodine Prep (NDC 71622-003). 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, use:, warnings:, keep out of reach of children., do not use:, stop use and ask a doctor if:, 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% (w/w) (equivalent to 1 % titratable iodine)

Purpose

Antiseptic

Use:

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

Warnings:

  • For external use only

Keep Out Of Reach Of Children.

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

Do Not Use:

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

Stop Use And Ask A Doctor If:

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

Directions:

  • Clean the treatment area
  • Apply a small amout of this product on the area 1~3 times daily 
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Inactive Ingredient:

Purified Water

Package Labeling:

Label3 (Label3)

Label3 (Label3)

* Please review the disclaimer below.