Important:REGRANEX is for use on the skin only (topical). Do not use REGRANEX near or in your mouth, eyes, or vagina.

What is the most important information I should know about REGRANEX?

REGRANEX may cause serious side effects, including:

Risk of cancer.Cancers have happened in areas away from the REGRANEX application site. You and your healthcare provider should carefully consider whether you will use REGRANEX if you have cancer.

What is REGRANEX?

REGRANEX is a prescription medicine that is used with good ulcer care practice for the treatment of diabetic sores (ulcers) of your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs and feet.

It is not known if REGRANEX is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation).

It is not known if REGRANEX is safe and effective in children under 16 years of age.

Who should not use REGRANEX?

Do not use REGRANEXif you have a cancer at the application site.

Before using REGRANEX, tell your healthcare provider about all of your medical conditions, including if you:

• have cancer.
• are pregnant or plan to become pregnant. It is not known if REGRANEX will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if REGRANEX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REGRANEX.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use REGRANEX?

Read the Instructions for Use for detailed information about the right way to apply REGRANEX.

• Use REGRANEX together with good ulcer care, as prescribed by your healthcare provider. This includes following your healthcare provider's instructions about not putting weight (non-weight bearing) on the affected leg and foot.
• Use REGRANEX exactly as your healthcare provider tells you to use it.
• The amount of REGRANEX you will apply will depend on the size of your ulcer. Your healthcare provider should check the size of your ulcer every 1 to 2 weeks. Your healthcare provider may change the amount of REGRANEX to be applied to your ulcer as the size of your ulcer changes.

What are the possible side effects of REGRANEX?

REGRANEX may cause serious side effects.

• See "What is the most important information I should know about REGRANEX?"
• Application site reactions.Tell your healthcare provider if you have any skin reactions such as burning sensation at the site of application during treatment with REGRANEX. Your healthcare provider may temporarily stop or completely stop treatment with REGRANEX if you have skin reactions.

The most common side effect of REGRANEXis red skin rashes.

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

You may also report side effects to Smith & Nephew, Inc. at 1-800-441-8227.

How should I store REGRANEX?

• Store REGRANEX in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze REGRANEX.
• Do not use REGRANEX after the expiration date on the bottom (sealed end) of the tube.
• Throw away your REGRANEX that is out of date or no longer needed for your treatment.

Keep REGRANEX and all medicines out of the reach of children.

General information about the safe and effective use of REGRANEX

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REGRANEX for a condition for which it was not prescribed. Do not give REGRANEX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about REGRANEX that is written for health professionals.