Renova (Page 3 of 4)

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, mitigation of fine facial wrinkles with RENOVA (tretinoin cream) 0.02% may be postponed in nursing mothers until after completion of the nursing period.

Pediatric Use:

Safety and effectiveness in patients less than 18 years of age have not been established.

Geriatric Use:

In clinical studies with RENOVA (tretinoin cream) 0.02%, patients aged 65 to 71 did not demonstrate a significant difference for improvement in fine wrinkling when compared to patients under the age of 65. Patients aged 65 and over may demonstrate slightly more irritation, although the differences were not statistically significant in the clinical studies for RENOVA (tretinoin cream) 0.02%. Safety and effectiveness of RENOVA (tretinoin cream) 0.02% in individuals older than 71 years of age have not been established.

ADVERSE REACTIONS

(See WARNINGS and PRECAUTIONS.)

In double-blind, vehicle-controlled studies involving 339 patients who applied RENOVA (tretinoin cream) 0.02% to their faces, adverse reactions associated with the use of RENOVA (tretinoin cream) 0.02% were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus. In 32% of all study patients, skin irritation was reported that was severe, led to temporary discontinuation of RENOVA (tretinoin cream) 0.02%, or led to use of a mild topical corticosteroid. About 7% of patients using RENOVA (tretinoin cream) 0.02%, compared to less than 1% of the control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids to alleviate local irritation. About 4% of patients had to discontinue use of RENOVA (tretinoin cream) 0.02% because of adverse reactions.

Approximately 2% of spontaneous postmarketing adverse event reporting for RENOVA (tretinoin cream) 0.05% were for skin hypo- or hyperpigmentation. Other spontaneously reported adverse events for RENOVA (tretinoin cream) 0.05% predominantly appear to be local reactions similar to those seen in clinical trials.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

DOSAGE AND ADMINISTRATION

Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy.
Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face.
Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is inherently sensitive to sunlight.
Do NOT use RENOVA (tretinoin cream) 0.02% if the patient is also taking drug(s) known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

RENOVA (tretinoin cream) 0.02% should be applied to the face once a day in the evening, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying RENOVA (tretinoin cream) 0.02%. The patient should apply a small pearl-sized (about ¼ inch or 5 mm diameter) amount of cream to cover the entire affected area lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of RENOVA (tretinoin cream) 0.02% may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of fine facial wrinkling may occur gradually over the course of therapy. Up to 6 months of therapy may be required before the effects are seen.

With discontinuation of RENOVA (tretinoin cream) 0.02% therapy, some patients may lose the mitigating effects of RENOVA (tretinoin cream) 0.02% on fine facial wrinkles. The safety and effectiveness of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with RENOVA (tretinoin cream) 0.02% may use cosmetics but the areas to be treated should be cleansed before the medication is applied (see PRECAUTIONS).

HOW SUPPLIED

RENOVA® (tretinoin cream), 0.02% is available in tubes containing 20 grams (NDC 0187-5150-20), 40 grams (NDC 0187-5150-40), 60 grams (NDC 0187-5150-60), and in pumps containing 44 grams (NDC 0187-5150-44).

Storage:

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

QUESTIONS:

Physicians and Pharmacists can call 1-800-321-4576, from 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday.

Manufactured for:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
RENOVA and Retin-A are trademarks of Bausch Health Companies Inc. or its affiliates.

© 2019 Bausch Health Companies Inc. or its affiliates

Rev. 09/2019

9418703

9418803

RENOVA
(TRETINOIN CREAM)
0.02%
RENOVA (reh-NO-vah)
Generic Name: Tretinoin Cream (0.02%)
Use only on the Face

Read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This leaflet does not take the place of talks with your doctor. It is important for you to talk with your doctor about how to use RENOVA® (tretinoin cream) 0.02% for the best results and how to reduce side effects.

What is the Most Important Information about RENOVA (tretinoin cream) 0.02%?

RENOVA (tretinoin cream) 0.02% is a serious medicine. Do not use RENOVA (tretinoin cream) 0.02% if you are pregnant or attempting to become pregnant. If you become pregnant while using RENOVA (tretinoin cream) 0.02%, please contact your doctor immediately.

Avoid sunlight and other medicines that may increase your sensitivity to sunlight (see “Who should not use RENOVA (tretinoin cream) 0.02%?”).

RENOVA (tretinoin cream) 0.02% does not remove wrinkles or repair sun-damaged skin. (see “What is RENOVA (tretinoin cream) 0.02%? ” for more details.)

What is RENOVA (tretinoin cream) 0.02%?

RENOVA (tretinoin cream) 0.02% is a prescription medicine that may reduce fine facial wrinkles. It is for patients who are using a total skin care and sunlight avoidance program. RENOVA (tretinoin cream) 0.02% does not remove wrinkles or repair sun-damaged skin. RENOVA (tretinoin cream) 0.02% does not work for everyone who uses it. It may work better for some patients than for others. RENOVA (tretinoin cream) 0.02% should be used only under the guidance of your doctor as part of a sunlight avoidance and total skin care program. This program should include avoiding sunlight as much as possible, using clothing to protect you from sunlight, using sunscreens with a minimum SPF of 15, and using face creams that add moisture to the skin.

When you use RENOVA (tretinoin cream) 0.02%, you will not see improvement right away. Generally, you may notice some effects in 3 to 4 months. If RENOVA (tretinoin cream) 0.02% treatment is stopped, the improvement may gradually disappear.

The use of RENOVA (tretinoin cream) 0.02% in patients for more than 52 weeks has not been studied. Therefore, it is not known if RENOVA (tretinoin cream) 0.02% is safe or works if used longer than 52 weeks. In a study in people with medium to dark skin color, RENOVA (tretinoin cream) 0.02% has not demonstrated a benefit over a sunlight avoidance and total skin care program. RENOVA (tretinoin cream) 0.02% has not been studied in people with visible actinic keratoses or in people with a history of skin cancer.

Who should not use RENOVA (tretinoin cream) 0.02%?

Do not use RENOVA (tretinoin cream) 0.02% if:

you are pregnant or plan to become pregnant. If you become pregnant while using RENOVA (tretinoin cream) 0.02%, please contact your doctor immediately.
you are sunburned or your skin is irritated.
you are highly sensitive to sunlight.
you are allergic to any of the ingredients in RENOVA (tretinoin cream) 0.02%. The active ingredient is tretinoin. Ask your doctor or pharmacist about the inactive ingredients.

RENOVA (tretinoin cream) 0.02% can cause increased skin irritation and increased chance of sunburn.

Tell your doctor if you have any skin condition. RENOVA (tretinoin cream) 0.02% may not be right for you.

Because RENOVA (tretinoin cream) 0.02% may make your skin more likely to burn from sunlight, tell your doctor if you are using other medicines that increase sensitivity to sunlight. You should not use RENOVA (tretinoin cream) 0.02% with such medicines. These include, but are not limited to:

thiazides (to treat high blood pressure)
tetracyclines, fluoroquinolones, sulfonamides (to treat infection)
phenothiazines (to treat serious emotional problems)

If you are taking any prescription or non-prescription medicines, check with your doctor to make sure you can use RENOVA (tretinoin cream) 0.02% with them.

We do not know if RENOVA (tretinoin cream) 0.02% is passed to infants through breast milk. Therefore, tell your doctor if you are breast feeding.

How should I use RENOVA (tretinoin cream) 0.02%?

Use RENOVA (tretinoin cream) 0.02% as part of a total skin care and sun avoidance program. Follow your doctor’s instructions on how to use RENOVA (tretinoin cream) 0.02%. RENOVA (tretinoin cream) 0.02% is usually applied to the face once a day in the evening, following the three steps listed below:

1.
Gently wash your face with a mild soap.
2.
Pat the skin dry and wait 20 to 30 minutes before applying RENOVA (tretinoin cream) 0.02%.
3.
TUBE: Squeeze a small amount of RENOVA (tretinoin cream) 0.02% (the size of a pearl — about 1/4 inch or 5 mm diameter) on your fingertip, and apply to your face.

PUMP: Fully depress the pump twice to dispense a small amount of RENOVA (tretinoin cream) 0.02% (the size of a pearl—about 1/4 inch or 5 mm diameter) on your fingertip, and apply to your face.

This should be enough to cover your affected area lightly.

Be especially careful when applying RENOVA (tretinoin cream) 0.02% to avoid your eyes, ears, nostrils, angles of the nose, and mouth. RENOVA (tretinoin cream) 0.02% may cause severe redness, itching, burning, stinging, and peeling if used on these areas.

Using too much RENOVA (tretinoin cream) 0.02% may increase discomfort and skin redness and peeling.

You may use cosmetics 1 hour after applying RENOVA (tretinoin cream) 0.02%. If you do, be sure to clean your face before applying RENOVA (tretinoin cream) 0.02% again. Skin moisturizers should be used at least every morning to protect the treated areas from dryness.

Use sunscreen and wear protective clothing to protect the treated areas from sunlight. If you sunburn easily, or if you spend a lot of time exposed to sunlight, be especially careful to protect your skin.

What should I avoid while using RENOVA (tretinoin cream) 0.02%?

RENOVA (tretinoin cream) 0.02% can make your treated skin more sensitive to sunlight. Therefore, keep out of the sunlight as much as possible and do not use sunlamps. Avoid as much as possible products that can increase skin irritation, such as:

other skin medicines
medicated or abrasive (rough) soaps
permanent wave solutions
chemical hair removers or waxes
electrolysis
products with alcohol, spices, astringents, or lime
cleaners, shampoos, or cosmetics with a strong drying effect
other products that may irritate your skin

What are the possible side effects of RENOVA (tretinoin cream) 0.02%?

You may feel brief warmth or stinging on your skin after you use RENOVA (tretinoin cream) 0.02%. Most patients report peeling, dry skin, burning, stinging, itching, and redness. These are usually mild to moderate and occur early in treatment. Contact your doctor if the side effects are a problem.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Only use RENOVA (tretinoin cream) 0.02% to treat the condition that your doctor has prescribed it for. Do not give RENOVA (tretinoin cream) 0.02% to other people. It may harm them.

This leaflet summarizes the most important information about RENOVA (tretinoin cream) 0.02%. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about RENOVA (tretinoin cream) 0.02% that is written for health professionals.

Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufactured for: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada
RENOVA is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2019 Bausch Health Companies Inc. or its affiliates
Rev. 09/2019
9418703

9418803

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