Betadine Solution
FDA Label NDC 67618-151

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Betadine (NDC 67618-151). 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 drug facts, purpose, uses, warnings, do not use this product, when using this product, stop use and ask a doctor, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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