Duraprep (Topical application)

Iodine povacrylex and isopropyl alcohol topical is used to clean the skin before surgery and helps reduce bacteria that may 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, including redness, itching, or burning in the area where you applied this medicine.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a choice you will make with your doctor. For this medicine, please keep the following in mind:

Allergies

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

Pediatric

Using this medicine in children younger than 2 months of age is not recommended because it may cause serious skin irritation and hypothyroidism (low thyroid levels).

Geriatric

There is no information available about how age affects the effects of Duraprep™ in older patients.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there could be an interaction. In these situations, your doctor might adjust the dose or take other precautions. Tell 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 used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

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

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately 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 occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may 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.