REGRANEX (Page 4 of 4)

INSTRUCTIONS FOR USE

REGRANEX ® (RE-GRAN-IX)

(becaplermin)

gel

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

Read these Instructions for Use before you start using REGRANEX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Follow your healthcare provider’s instructions for measuring and applying REGRANEX.

  • Apply REGRANEX one time a day to ulcer area.
  • Do not use more than your prescribed dose of REGRANEX or apply more often than every 24 hours.
  • Do not let the tip of your REGRANEX tube touch the ulcer or any other surface.
  • Put the REGRANEX tube in the refrigerator after each use.

Supplies you need to apply REGRANEX:

  • Clean cotton swab, tongue depressor or similar application aid
  • Ruler or measuring tape
  • Clean firm, non-absorbable surface, such as wax paper
  • Saline moistened gauze dressing

Step 1. Preparing the REGRANEX dose.

  • Wash your hands well before you apply REGRANEX.
  • Remove the cap from the REGRANEX tube and use the top of the cap to pierce the foil seal on the top of the tube by pushing or screwing the cap in.
  • Carefully measure the amount of REGRANEX that your healthcare provider tells you to use.
  • Squeeze the amount of REGRANEX needed for your ulcer on to the clean, firm non-absorbable surface and measure to the correct length with a ruler as prescribed by your healthcare provider.
  • Close the REGRANEX tube tightly.

Step 2. Applying REGRANEX.

  • Use a clean cotton swab, tongue depressor, or similar application aid to spread the measured amount of REGRANEX in a thin even layer over the ulcer area.
  • Cover the application site with a saline moistened gauze dressing.
  • Wash your hands well.

Step 3. Removing REGRANEX.

  • Remove REGRANEX after 12 hours.
  • Wash your hands well.
  • Remove the saline moistened gauze dressing.
  • Rinse the ulcer with saline or water to remove any REGRANEX gel.
  • Cover the ulcer with a new moistened dressing.
  • Wash your hands well.

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  • Throw away your REGRANEX that is out of date or no longer needed for your treatment.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.

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration. Issued: 08/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Tube LABEL.PRINCIPAL DISPLAY PANEL

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REGRANEX
becaplermin gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50484-810
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BECAPLERMIN (BECAPLERMIN) BECAPLERMIN 100 ug in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
ACETIC ACID
LYSINE HYDROCHLORIDE
METACRESOL
METHYLPARABEN
PROPYLPARABEN
SODIUM ACETATE
SODIUM CHLORIDE
WATER
Product Characteristics
Color YELLOW (CLEAR, COLORLESS TO STRAW-COLORED) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50484-810-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (50484-810-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103691 11/01/2011
Labeler — Smith & Nephew, Inc. (827731451)
Establishment
Name Address ID/FEI Operations
Renaissance Lakewood LLC 077744035 MANUFACTURE (50484-810), pack (50484-810), analysis (50484-810)

Revised: 08/2019 Smith & Nephew, Inc.

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