FDA Label for Betadine Surgical Scrub

Drug Facts

Active ingredient

Povidone-iodine, 7.5% (0.75% available iodine)

Purpose

Antiseptic

Uses

• for preparation of the skin prior to surgery
• helps to reduce bacteria that potentially can cause skin infection
• for handwashing to reduce bacteria on the skin
• significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Do Not Use This Product

• in the eyes

When Using This Product

• prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
• in pre-operative prepping, avoid “pooling” beneath the patient

Stop Use And Ask A Doctor

• if irritation and redness develop
• in rare instances of local irritation or sensitivity

Directions

• Surgical hand scrub:
  • wet hands with water
  • spread about 5 cc (1 teaspoonful) of Scrub over both hands and forearms
  • without adding more water, scrub thoroughly for 2 1/2 to 3 minutes
  • use a sponge if desired. Clean thoroughly under fingernails.
  • add a little water and develop copious suds. Rinse thoroughly under running water.
  • repeat the entire procedure using another 5 cc of Scrub
  • Antiseptic hand wash:
    • wet hands with water and pour about 5 cc of Scrub on hands
    • rub hands vigorously together for at least 15 seconds, covering all surfaces
    • rinse and dry with a disposable towel
    • Patient pre-operative skin preparation:
      • wet skin with water
      • apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes
      • rinse off using sterile gauze saturated with water
      • the area may then be painted with BETADINE Solution and allowed to dry
      
      

Other Information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• store in original container

Inactive Ingredients

ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, sodium hydroxide