Klofensaid II (Page 7 of 7)

Patient Instructions for Use

Diclofenac Sodium Topical Solution

Read the Medication Guide that comes with diclofenac sodium topical solution first. Be sure that you read, understand, and follow these Instructions for Use before you use diclofenac sodium topical solution for the first time.Important: For use on the skin only (topical). Do not get diclofenac sodium topical solution in your eyes, nose or mouth.

Before you use diclofenac sodium topical solution:

  • Apply diclofenac sodium topical solution exactly as your healthcare provider tells you. Talk with your healthcare provider or pharmacist if you are not sure.
  • Only use diclofenac sodium topical solution to treat pain from osteoarthritis in your knee or knees.
  • Apply diclofenac sodium topical solution on clean dry skin that does not have any cuts, infections or rashes.
  • Use diclofenac sodium topical solution 4 times each day on your knee or knees as prescribed.
  • Your total dose for each knee is 40 drops of diclofenac topical solution, each time you use it.
  • If you get diclofenac sodium topical solution in your eyes, rinse your eyes right away with water or saline. Call your healthcare provider if your eyes are irritated for more than one hour.

Steps for using diclofenac sodium topical solution:

Step 1. Wash your hands with soap and water before and after applying diclofenac sodium topical solution.

Step 2. Put 10 drops of diclofenac sodium topical solution either on your hand or directly on your knee (See Figure A).

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Step 3. Spread diclofenac sodium topical solution evenly on the front, back and sides of your knee (see Figures B and C). Repeat steps 2 and 3, three times so that your knee is completely covered with a total of 40 drops of diclofenac sodium topical solution.

Figure B

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Figure C

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Step 4. If your healthcare provider has prescribed diclofenac sodium topical solution for both knees, repeat steps 2 and 3 for the other knee.

After you use diclofenac sodium topical solution:

Wash your hands with soap and water right away after applying diclofenac sodium topical solution.
Do not

  • touch the treated knee or allow another person to touch the knee treated with diclofenac sodium topical solution until your knee is completely dry.
  • cover your knee with clothing until your knee is completely dry.
  • put sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medicines on your knee until it is completely dry.
  • take a shower or a bath for at least 30 minutes after you put diclofenac sodium topical solution on your knee(s).
  • use heating pads or apply bandages to the skin where you have applied diclofenac sodium topical solution.
  • use sunlamps and tanning beds. Protect your treated knee from sunlight. Wear clothes that cover your skin if you have to be in sunlight.

How should I store diclofenac sodium topical solution?

  • Store diclofenac sodium topical solution between 68°F to 77°F (20°C to 25°C).

Keep diclofenac sodium topical solution and all medicines out of the reach of children.

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

Brands mentioned are trademarks of their respective owners.

Manufactured by:
IGI Laboratories, Inc.
Buena, NJ 08310

Distributed by:
PureTek Corporation
San Fernando, CA 91340

PRINCIPAL DISPLAY PANEL

Klofensaid II™ contains two bottles of Diclofenac Sodium Topical Solution (1.5% w/w), 5 fl oz / 150 mL in each bottle.

Dispense Medication Guide To Each Patient.

Rx Only For External Use Only

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KLOFENSAID II diclofenac sodium solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-375
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diclofenac Sodium (Diclofenac) Diclofenac Sodium 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
dimethyl sulfoxide
propylene glycol
alcohol
glycerin
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-375-00 2 BOTTLE in 1 PACKAGE contains a BOTTLE
1 150 mL in 1 BOTTLE This package is contained within the PACKAGE (59088-375-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202769 03/01/2016
Labeler — PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
IGI Labs, Inc 011036910 manufacture (59088-375)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 pack (59088-375)

Revised: 03/2016 PureTek Corporation

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