Renova

What is Renova?

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.

Description

RENOVA® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a cream base. Tretinoin is a yellow to light-orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44. The structural formula is represented below:

Tretinoin is available as RENOVA at a concentration of 0.02% w/w in an oil-in-water emulsion formulation consisting of benzyl alcohol, butylated hydroxytoluene, caprylic/capric triglyceride, cetyl alcohol, edetate disodium, methylparaben, propylparaben, purified water, stearic acid, stearyl alcohol, steareth 2, steareth 20, and xanthan gum.

What is the most important information I should know about Renova?

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?”).

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

Who should not use Renova?

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.

What should I tell my healthcare provider before using Renova?

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?

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?

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?

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 information about the safe and effective use of Renova

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.

How should I store Renova?

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

What are the ingredients in Renova?

Active ingredient: Tretinoin

Inactive ingredients: Benzyl Alcohol, Butylated Hydroxytoluene, Medium-Chain Triglycerides, Cetyl Alcohol, Edetate Disodium, Methylparaben, Propylparaben, Water, Stearic Acid, Stearyl Alcohol, Steareth-2, Steareth-20, Xanthan Gum

Label

PACKAGE/LABEL DISPLAY PANEL

 

• NDC 0187-5150-40Rx onlyRENOVA®
  (TRETINOIN CREAM)
  0.02%TUBE

  For Topical Use Only

  Net Wt. 40 g

  Ortho Dermatologics

SRC: NLM .