Kerydin (Page 3 of 4)

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

The patient should be told the following:

  • The impact of nail polish or other cosmetic nail products on the efficacy of KERYDIN has not been evaluated.
  • Inform a health care professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling).
  • Product is flammable. Avoid use near heat or open flame.

Manufactured for:
Pfizer Labs, Division of Pfizer Inc, NY, NY 10017

Distributed by:
PharmaDerm®

A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747 USA

KERYDIN® is a trademark of Anacor Pharmaceuticals, Inc.
© 2015 Anacor Pharmaceuticals, Inc.

U.S. Patent Nos. 7,767,657 and 7,582,621LAB-1202-2.0

PATIENT INFORMATIONKERYDIN® (ker’ i din)(tavaborole) topical solution, 5%
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised August/2018
Important information: KERYDIN is for use on toenails only. Do not use KERYDIN in your mouth, eyes, or vagina.
What is KERYDIN? KERYDIN is a prescription medicine used to treat fungal infections of the toenails.It is not known if KERYDIN is safe and effective in children less than 6 years age.
Before using KERYDIN, tell your healthcare provider about all of your medical conditions, including if you:
  • are pregnant or plan to become pregnant. It is not known if KERYDIN can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if KERYDIN passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during your treatment with KERYDIN.
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 KERYDIN? See the “Instructions for Use” at the end of this Patient Information for detailed information about the right way to use KERYDIN.
  • Use KERYDIN exactly as your healthcare provider tells you to use it.
  • Apply KERYDIN to your affected toenails 1 time each day.
  • KERYDIN is used for 48 weeks.
  • It is not known if the use of nail polish or other cosmetic nail products (such as gel nails or acrylic nails) will affect how KERYDIN works.
What should I avoid while using KERYDIN?
  • KERYDIN is flammable. Avoid heat and flame while applying KERYDIN to your toenail.
What are the possible side effects of KERYDIN? The most common side effects of KERYDIN include: skin peeling, ingrown toenail, redness, itching, and swelling.KERYDIN may cause irritation at or near the application site. Tell your healthcare provider if you develop irritation at the application site that does not go away. These are not all of the possible side effects of KERYDIN.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store KERYDIN?
  • Store KERYDIN at room temperature, between 68°F to 77°F (20°C to 25°C).
  • KERYDIN is flammable. Keep away from heat and flame.
  • Keep the bottle tightly closed.
  • Safely throw away KERYDIN after 3 months of inserting the dropper.
Keep KERYDIN and all medicines out of the reach of children.
General information about the safe and effective use of KERYDIN Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use KERYDIN for a condition for which it was not prescribed. Do not give KERYDIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KERYDIN that is written for health professionals.
What are the ingredients in KERYDIN? Active ingredient: tavaboroleInactive ingredients: alcohol, edetate calcium disodium and propylene glycolManufactured for: Pfizer Labs, Division of Pfizer Inc, NY, NY 10017Distributed by: PharmaDerm® , a division of Fougera Pharmaceuticals, Inc., Melville, New York 11747 USAFor more information, call PharmaDerm ® , a division of Fougera Pharmaceuticals, Inc., at 1-800-645-9833.LAB-1203-2.0

Instructions for Use
KERYDIN® (ker’ i din)(tavaborole) topical solution, 5%

Important information: KERYDIN is for use on toenails only. Do not use KERYDIN in your mouth, eyes, or vagina.

Read the Instructions for Use that comes with KERYDIN before you start using it. Talk to your healthcare provider if you have any questions.

How to apply KERYDIN:

Your toenails should be clean and dry before you apply KERYDIN.

Step 1: Before you apply KERYDIN to your affected toenail for the first time, remove the cap from the KERYDIN bottle. (See Figure A) Throw away the cap.
Step 2: Remove the wrapping from the dropper that comes with KERYDIN. Insert the dropper into the KERYDIN bottle. (See Figure B)

Figures A and B
(click image for full-size original)

Figure A Figure B
Only apply KERYDIN using the provided dropper. Do not use the dropper for any other purpose.
Step 3: With the dropper inserted into the KERYDIN, squeeze the bulb and then release the bulb to draw KERYDIN into the dropper.
Step 4: Remove the dropper from the bottle and hold the dropper tip over your affected toenail.
Step 5: Slowly squeeze the bulb to apply KERYDIN to your toenail. Apply enough solution to completely cover your toenail. You may need to use more than one drop. (See Figure C)

Figure C
(click image for full-size original)

Figure C
Step 6: Use the dropper tip to gently spread KERYDIN to cover the entire toenail up to the edges of the toenail. (See Figure D)

Figure D

Figure D
Step 7: In addition to the top of the toenail, also apply KERYDIN under the tip of the toenail. Use the dropper tip to gently spread KERYDIN under the entire tip of the toenail. (See Figures E and F)

Figures E and F
(click image for full-size original)

Figure E Figure F
Step 8: Repeat Steps 3 to 7 to apply KERYDIN to each affected toenail.
Step 9: Let the KERYDIN dry completely. This may take a couple of minutes. Avoid getting KERYDIN on skin that is not surrounding the treated toenail(s).If KERYDIN comes in contact with surrounding skin, use a tissue to wipe any excess solution from the surrounding skin. Do not wipe KERYDIN off of your toenails.
Step 10:After applying KERYDIN to your toenails, insert the dropper back into the bottle and screw it on tightly.
Step 11: Wash your hands with soap and water after applying KERYDIN.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for: Pfizer Labs, Division of Pfizer Inc, NY, NY 10017

Distributed by: PharmaDerm® , a division of Fougera Pharmaceuticals, Inc., Melville, New York 11747 USA

LAB-1204-2.0

Revised: 08/2018

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