Tretinoin cream

A brief sensation of warmth or stinging may occur immediately after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2-4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes).If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to decrease how often you use tretinoin, change the strength, or have you stop using it.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Notify your doctor if you experience: blistering, crusting, severe burning/swelling of the skin, eye redness and watering (conjunctivitis), eyelid swelling, darkening or lightening of skin color.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

• RENOVA® (tretinoin cream) 0.02% is a dermal irritant, and the results of continued irritation of the skin for greater than 52 weeks in chronic use with RENOVA® (tretinoin cream) 0.02% are not known. There is evidence of atypical changes in melanocytes and keratinocytes and of increased dermal elastosis in some patients treated with RENOVA® (tretinoin cream) 0.05% for longer than 48 weeks. The significance of these findings and their relevance for RENOVA® (tretinoin cream) 0.02% are unknown.
• RENOVA® (tretinoin cream) 0.02% should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Exposure to sunlight (including sunlamps) should be avoided or minimized during use of RENOVA® (tretinoin cream) 0.02% because of heightened sunburn susceptibility. Patients should be warned to use sunscreens (minimum SPF of 15) and protective clothing when using RENOVA® (tretinoin cream) 0.02%. Patients with sunburn should be advised not to use RENOVA® (tretinoin cream) 0.02% until fully recovered. Patients who may have considerable sun exposure, e.g., due to their occupation, and those patients with inherent sensitivity to sunlight should exercise caution when using RENOVA® (tretinoin cream) 0.02% and follow the precautions outlined in the Patient Package Insert.

RENOVA® (tretinoin cream) 0.02% should be kept out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use less medication, decrease the frequency of application, discontinue use temporarily, or discontinue use altogether and consider additional appropriate therapy.

Tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution in patients with this condition.

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.

FDA pregnancy category C. It is not known whether tretinoin topical is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Tretinoin topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• It is used to treat pimples (acne).
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• It may take several weeks to see the full effects.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• Do not put on sunburned skin.
• Do not put on cuts, scrapes, or damaged skin.
• Practice good skin care and avoid the sun.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Some weather conditions may irritate the skin. Talk with the doctor.
• Use of other skin products while using tretinoin cream may cause more irritation.
• Talk with your doctor before you use other drugs or products on your skin.
• You may use make-up unless your doctor has told you not to. If you will be using make-up, clean the area to be treated before putting this drug on.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking tretinoin cream, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take tretinoin cream by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If you get this medicine in any of these areas, rinse well with water.
• Follow how to use as you have been told by the doctor or read the package insert.
• Put on at bedtime.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Wait 20 to 30 minutes before use.
• Put a thin layer on the affected skin and rub in gently.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

Tretinoin Cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly.

Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.

Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.

During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.

Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.

Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.

Patients treated with tretinoin acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (see Precautions)

Tretinoin is supplied as:

Tretinoin Cream

NDC Code	Strength	Quantity
62032-414-20	0.025% Cream	20 g
62032-412-20	0.05% Cream	20 g
62032-417-20	0.1% Cream	20 g