TRETIN-X- tretinoin gel 
TRETIN-X- tretinoin cream 
Triax Pharmaceuticals, LLC

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TRETIN-X®
Tretinoin Gel, Cream

For External Use Only.
Not For Ophthalmic Use.
Rx Only


PATIENT INSTRUCTIONS
Acne Treatment
IMPORTANT
Read Directions Carefully Before Using


Read Directions Carefully Before Using.

THIS LEAFLET TELLS YOU ABOUT TRETIN-X® ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR'S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE LONG-TERM SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR.


WARNINGS

TRETIN-X® GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. Keep out of reach of children. Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C).


PRECAUTIONS

The effects of the sun on your skin. As you know, overexposure to natural sunlight or the artificial sunlight of a sunlamp can cause sunburn. Overexposure to the sun over many years may cause premature aging of the skin and even skin cancer. The chances of these effects occurring will vary depending on skin type, the climate and the care taken to avoid overexposure to the sun. Therapy with TRETIN-X® may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized.

Laboratory findings. When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient in TRETIN-X®, tretinoin. In some studies, under different conditions, however, when mice treated with TRETIN-X® were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that TRETIN-X® alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing.

Use caution in the sun. When outside, even on hazy days, areas treated with TRETIN-X® should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection). For extended sun exposure, protective clothing, like a hat, should be worn. Do not use artificial sunlamps while you are using TRETIN-X®. If you do become sunburned, stop your therapy with TRETIN-X® until your skin has recovered.

Avoid excessive exposure to wind or cold. Extremes of climate tend to dry or burn normal skin. Skin treated with TRETIN-X® may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.

Possible problems. The skin of certain sensitive individuals may become excessively red, swollen, blistered or crusted. If you are experiencing severe or persistent irritation, discontinue the use of TRETIN-X® and consult your physician.

There have been reports that, in some patients, areas treated with TRETIN-X® developed a temporary increase or decrease in the amount of skin pigment (color) present. The pigment in these areas returned to normal either when the skin was allowed to adjust to TRETIN-X® or therapy was discontinued.

Use other medication only on your doctor's advice. Only your physician knows which other medications may be helpful during treatment and will recommend them to you if necessary. Follow the physician's instructions carefully. In addition, you should avoid preparations that may dry or irritate your skin. These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos and hair permanent solutions. Do not allow anyone else to use this medication.

Do not use other medications with TRETIN-X® which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling.

If you are pregnant, think you are pregnant or are nursing an infant: No studies have been conducted in humans to establish the safety of TRETIN-X® in pregnant women. If you are pregnant, think you are pregnant, or are nursing a baby, consult your physician before using this medication.


AND WHILE YOU'RE ON TRETIN-X® THERAPY

Use a mild, non-medicated soap. Avoid frequent washings and harsh scrubbing. Acne isn't caused by dirt, so no matter how hard you scrub, you can't wash it away. Washing too frequently or scrubbing too roughly may at times actually make your acne worse. Wash your skin gently with a mild, bland soap. Two or three times a day should be sufficient. Pat skin dry with a towel. Let the face dry 20-30 minutes before applying TRETIN-X®. Remember, excessive irritation such as rubbing, too much washing, use of other medications not suggested by your physician, etc., may worsen your acne.


HOW TO USE TRETIN-X®

To get the best results with TRETIN-X® therapy, it is necessary to use it properly. Forget about the instructions given for other products and the advice of friends. Just stick to the special plan your doctor has laid out for you and be patient. Remember, when TRETIN-X® is used properly, many users see improvement by 12 weeks. AGAIN, FOLLOW INSTRUCTIONS - BE PATIENT - DON'T START AND STOP THERAPY ON YOUR OWN - IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR.

To help you use the medication correctly, keep these simple instructions in mind.


WHAT TO EXPECT WITH YOUR NEW TREATMENT

TRETIN-X® works deep inside your skin and this takes time. You cannot make TRETIN-X® work any faster by applying more than one dose each day, but an excess amount of TRETIN-X® may irritate your skin. Be patient.

There may be some discomfort or peeling during the early days of treatment. Some patients also notice that their skin begins to take on a blush.

These reactions do not happen to everyone. If they do, it is just your skin adjusting to TRETIN-X® and this usually subsides within two to four weeks. These reactions can usually be minimized by following instructions carefully. Should the effects become excessively troublesome, consult your doctor.

BY THREE TO SIX WEEKS, some patients notice an appearance of new blemishes (papules and pustules). At this stage it is important to continue using TRETIN-X®.

If TRETIN-X® is going to have a beneficial effect for you, you should notice a continued improvement in your appearance after 6 to 12 weeks of therapy. Don't be discouraged if you see no immediate improvement. Don't stop treatment at the first signs of improvement.

Once your acne is under control you should continue regular application of TRETIN-X® until your physician instructs otherwise.


IF YOU HAVE QUESTIONS

All questions of a medical nature should be taken up with your doctor. For more information about TRETIN-X®, call our toll-free number: 1-800-978-5060. Call between 9:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday. [Addition of Triax logo, address, and call in number]


Manufactured for Triax Pharmaceuticals, LLC,
Cranford, NJ 07016
by DPT Laboratories, San Antonio, TX 78215

637F900
Rev 09/09

Revised: 10/2013
 
Triax Pharmaceuticals, LLC