Iodine povacrylex and isopropyl alcohol (Topical application)

Iodine povacrylex and isopropyl alcohol (Topical application) is used to clean the skin before surgery and helps lower the number of bacteria that can cause skin infections. It works by killing or stopping the growth of bacteria on the skin.

This medicine is available without a prescription.

Call your doctor if you have skin irritation that does not go away, such as redness, itching, or burning in the area where you used this medicine.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

It is not recommended to use this medicine in children younger than 2 months of age due to the risk of serious skin irritation and hypothyroidism (low thyroid levels).

Geriatric

There is no information available regarding the effects of Duraprep™ in older patients.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a possibility of interaction. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Open wounds—This medicine should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Blistering, burning, itching, peeling, skin rash, redness, swelling, or other signs of irritation on the skin

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Duraprep

Available Dosage Forms:

• Solution

Therapeutic Class: Antibacterial

You may be instructed to use this medicine at home. It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Duraprep™ should only be used on the skin. Do not use on open wounds or as a general skin cleanser. Do not get it in the eyes, ears, mouth, or nose. If it does get on these areas, rinse it off right away.

Follow your doctor's instructions about how to clean and care for your skin before and after you use this medicine. Make sure you understand all of the directions, and ask questions if you find something is not clear.

Duraprep™ is flammable. Keep it away from fire or flame. Use in a well-ventilated area. Do not microwave or heat the applicator.

To apply:

• Apply evenly to a clean, dry, intact skin. Do not scrub.
• Do not allow the solution to pool. Use a sponge applicator or towel to absorb excess solution.
• Avoid applying the solution into hairy areas.
• Use a sterile-gloved hand when applying to skin folds, fingers, or toes to hold the skin apart until completely dry.
• To reduce the risk of fire, wait until the solution is completely dry (at least 3 minutes on hairless skin or 1 hour in hair).

Storage

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Duraprep™ will not dissolve in water and may stain. Avoid contact with reusable items.