Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub Solution
FDA Label NDC 67326-352

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 Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub (NDC 67326-352). 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: for external use only, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone Iodine 7.5%

Purpose

Antiseptic

Uses

Patient preoperative skin preparation:

  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can cause skin infection

    • Surgical hand scrub:

    • Significantyl reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

Warnings: For External Use Only

Do not use

  • In the eyes
  • Heat prior to application
  • On individuals who are allergic or sensitive to Iodine

    • Stop use and ask a doctor if

    • Irritation and redness develop
    • If condition persists for more than 72 hous consult a doctor

Keep Out Of Reach Of Children

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

Directions

Patient preoperative skin preparation:

  • Clean the area
  • Apply product to the operative site prior to surgery
  • Scrub thoroughly for 5 minutes
  • Rinse off with a sterile gauze saturated with water

    • Surgical hand scrub:

    • Clean under nails with a nail pick. Nail should be maintained with a 1 millimeter free edge
    • Wet hands and forearms
    • Apply 5 millileters (teaspoonful) or palmfull to hands and forearms
    • Scub thoroughly for 5 minutes with a sterile brush
    • Paying particular attention to the nails, cuticles, and interdigital spaces
    • Rinse and repeat scrub

Other Information

Store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

Disodium Phosphate, Glycerin, Hidroxyethylcellulose, Monoethanolamine, Dionized Water

* Please review the disclaimer below.