Prep Solution
FDA Label NDC 67326-350

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Degasa Sa De Cv for the product Prep Solution (NDC 67326-350). 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, keep out of reach of children, directions, inactive ingredients, principal display panel, 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

Antiseptic

Uses

  • Health-care 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

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:

  • Apply product to the operative site prior to surgery

    • As a first aid antiseptic:

    • Clean the affected area
    • Apply a small amount of this product on the area 1-3 times daily

Inactive Ingredients

Citric Acid, Sodium Citrate, Glycerin, Tween 80, Disodium Phosphate, Purified Water

Principal Display Panel

* Please review the disclaimer below.