Patients should be advised that:

- hands should be washed thoroughly before applying REGRANEX Gel;

- the tip of the tube should not come into contact with the ulcer or any other surface; the tube should be recapped tightly after each use;

- a cotton swab, tongue depressor, or other application aid should be used to apply REGRANEX Gel;

- REGRANEX Gel should only be applied once a day in a carefully measured quantity (see DOSAGE AND ADMINISTRATION section). The measured quantity of gel should be spread evenly over the ulcerated area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The measured length of the gel to be squeezed from the tube should be adjusted according to the size of the ulcer. The amount of REGRANEX Gel to be applied daily should be recalculated at weekly or biweekly intervals by the physician or wound care giver;

Step-by-step instructions for application of REGRANEX Gel are as follows:

• Squeeze the calculated length of gel on to a clean, firm, non-absorbable surface,e.g., wax paper.
• With a clean cotton swab, tongue depressor, or similar application and spread the measured REGRANEX Gel over the ulcer surface to obtain an even layer.
• Cover with a saline moistened gauze dressing.

- after approximately 12 hours, the ulcer should be gently rinsed with saline or water to remove residual gel and covered with a saline-moistened gauze dressing (without REGRANEX Gel);

- it is important to use REGRANEX Gel together with a good ulcer care program, including a strict non-weight-bearing program;

- excess application of REGRANEX Gel has not been shown to be beneficial;

- REGRANEX Gel should be stored in the refrigerator. Do not freeze REGRANEX Gel;

- REGRANEX Gel should not be used after the expiration date on the bottom, crimped end of the tube.

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