1. Home
  2. Labeler Index
  3. Degasa Sa De Cv
  4. 67326-352
  5. Label Information: Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub

FDA Label for Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS: FOR EXTERNAL USE ONLY
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PACKAGE LABELING

Antiseptic Patient Preoperative Skin Preparation And Surgical Hand Scrub Product Label

The following document was submitted to the FDA by the labeler of this product Degasa Sa De Cv. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.