Complex A Tretinoin Cream

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

Complex A™ Tretinoin Cream, USP (Emollient) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs (see bullet 3 for populations in which effectiveness has not been established). COMPLEX A™ TRETINOIN CREAM, USP (EMOLLIENT) DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin.

• Complex A™ Tretinoin Cream, USP (Emollient) 0.05% has demonstrated NO MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangi-ectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.

• Complex A™ Tretinoin Cream, USP (Emollient) 0.05% should be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sun-screens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone.

• The effectiveness of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of Complex A™ Tretinoin Cream, USP (Emollient) 0.05%. Thus the effectiveness and safety of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% in these populations are not known at this time.

• Neither the safety nor the effectiveness of Complex A™ Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
• Neither the safety nor the efficacy of using Complex A™ Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials.
  (See WARNINGS section.)

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

• Complex A™ Tretinoin Cream, USP (Emollient) is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks in chronic long-term use are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with Complex A™ Tretinoin Cream, USP (Emollient) for longer than 48 weeks. The significance of these findings is unknown.
• Safety and effectiveness of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% in individuals with moderately or heavily pigmented skin have not been established.
• Complex A™ Tretinoin Cream, USP (Emollient) should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sul-fonamides) because of the possibility of augmented phototoxicity.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during use of Complex A™ Tretinoin Cream, USP (Emollient). Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Complex A™ Tretinoin Cream, USP (Emollient). Patients with sunburn should be advised not to use Complex A™ Tretinoin Cream, USP (Emollient) 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 particular caution when using Complex A™ Tretinoin Cream, USP (Emollient) and assure that the precautions outlined in the Patient Package Insert are observed.

Complex A™ Tretinoin Cream, USP (Emollient) 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.

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 will not lead to more rapid or better results, and marked redness, peeling, or discomfort may occur.

• Do NOT use Complex A™ Tretinoin Cream, USP (Emollient) if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy
• Do NOT use Complex A™ Tretinoin Cream, USP (Emollient) if the patient is sunburned or if the patient has eczema or other chronic skin condition(s)
• Do NOT use Complex A™ Tretinoin Cream, USP (Emollient) if the patient is inherently sensitive to sunlight
• Do NOT use Complex A™ Tretinoin Cream, USP (Emollient) 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.

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.

Complex A™ Tretinoin Cream, USP (Emollient) should be applied to the face once a day before retiring, 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 Complex A™ Tretinoin Cream, USP (Emollient). The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Complex A™ Tretinoin Cream, USP (Emollient) may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Complex A™ Tretinoin Cream, USP (Emollient) 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% therapy, a majority of patients will lose most mitigating effects of Complex A™ Tretinoin Cream, USP (Emollient) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Complex A™ Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks have not been established.

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

Patients treated with Complex A™ Tretinoin Cream, USP (Emollient) 0.05% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. (See PRECAUTIONS section.)

Complex A™ Tretinoin Cream, USP (Emollient) 0.05%

FOR TOPICAL USE ON THE FACE ONLY

What is the Most Important Information about Complex A™ Tretinoin Cream, USP (Emollient)?

Complex A™ Tretinoin Cream, USP (Emollient) is a serious medication. It does not eliminate wrinkles or repair sun-damaged skin. It may help treat fine wrinkles, spotty discoloration, and rough feeling skin, but it does not "cure" these conditions. Complex A™ Tretinoin Cream, USP (Emollient) should only be used under supervision of your health care provider as part of a broad skin care program. This program should include avoiding direct sunlight (by using protective clothing and sunscreens with a minimum SPF of 15) and using other moisturizing facial creams that do not contain tretinoin.

You should use Complex A™ Tretinoin Cream, USP (Emollient) only at bedtime. Do not use drying skin care products. Use the smallest amount of Complex A™ Tretinoin Cream, USP (Emollient) needed and avoid getting it in your eyes, ears, nose or mouth.

WARNING: Do not use Complex A™ Tretinoin Cream, USP (Emollient) if you are pregnant or attempting to become pregnant. Avoid sunlight and any other medicines that may increase your sensitivity to sunlight (see below).

Complex A™ Tretinoin Cream, USP (Emollient) has not been studied in people who are over 50 years of age or in people with moderately or darkly pigmented skin.

What is COMPLEX A™ TRETINOIN CREAM, USP (EMOLLIENT)?(WHAT CAN I EXPECT FROM COMPLEX A™ TRETINOIN CREAM, USP (EMOLLIENT)?)

Complex A™ Tretinoin Cream, USP (Emollient) is a serious medication that may help treat but will not "cure" fine wrinkles, spotty skin discoloration, and rough feeling skin.

Studies show that after 24 weeks, about 30% of the people who used Complex A™ Tretinoin Cream, USP (Emollient) for fine wrinkles or spotty discoloration had moderate improvement, another 35% had minimal improvement and 35% had no improve-ment. About 16% of the people who used Complex A™ Tretinoin Cream, USP (Emollient) 0.05% for rough skin had moderate improvement, 35% had minimal improve-ment, and 49% had no improvement. There is no evidence that Complex A ™ Tretinoin Cream, USP (Emollient) treats coarse skin, deep wrinkles, yellowing skin, or other skin care problems.

Complex A™ Tretinoin Cream, USP (Emollient) should be used as part of a broad skin care program. This program should include avoiding direct sunlight (by using protective clothing and sunscreens with a minimum SPF of 15) and using other moisturizing facial creams that do not contain tretinoin. Many people can achieve desired effects by using this program without using Complex A™ Tretinoin Cream, USP (Emollient). You should not use Complex A™ Tretinoin Cream, USP (Emollient) until you have tried a broad skin treatment program without Complex A™ Tretinoin Cream, USP (Emollient).

When you use Complex A™ Tretinoin Cream, USP (Emollient), improvement in fine wrinkling, spotty skin discoloration and rough skin is not immediate and occurs gradually over time. Generally, you may notice some effects in 3 to 4 months. The effects are usually most noticeable at about 6 months with little additional improvement after that time. If Complex A™ Tretinoin Cream, USP (Emollient) is stopped, the improvement will gradually diminish.

The safety of using Complex A™ Tretinoin Cream, USP (Emollient) daily for more than 48 weeks has not been established.

Who Should Not Use Complex A™ Tretinoin Cream, USP (Emollient)?

You should not use Complex A™ Tretinoin Cream, USP (Emollient) if you are sunburned or highly sensitive to the sun, if you have eczema, or if your skin is irritated. Complex A™ Tretinoin Cream, USP (Emollient) can cause increased skin irritation and increased susceptibility to sunburn.

Since Complex A™ Tretinoin Cream, USP (Emollient) may make your skin more sensitive to sunlight, you should tell your health care professional if you are also using other medicines that increase sensitivity to sunlight because you should not be using Complex A™ Tretinoin Cream, USP (Emollient) with these medicines. These include but are not limited to: thiazides (used to treat high blood pressure), tetracyclines, fluoroquino-lones or sulfonamides (used to treat infection), and phenothiazines (used to treat serious emotional problems). If you are taking any prescription medicines, non-prescription medicines or using any facial creams, check with a health care professional to make sure they do not interact with Complex A™ Tretinoin Cream, USP (Emollient).

Pregnancy Warning: Safe use during pregnancy has not been shown. There are reports of birth defects with laboratory animals and humans that were given tretinoin by mouth. You should not use Complex A™ Tretinoin Cream, USP (Emollient) if you are pregnant or trying to become pregnant.

It is not known if Complex A™ Tretinoin Cream, USP (Emollient) is passed to infants through breast milk. Safe use in children has not been shown.

The safety and effectiveness of Complex A™ Tretinoin Cream, USP (Emollient) for people over age 50 or with darker skin coloration has not been proven.

How should I use Complex A™ Tretinoin Cream, USP (Emollient)?

You should apply Complex A™ Tretinoin Cream, USP (Emollient) to your face once a day before retiring using only enough to cover the entire affected area lightly. Gently wash your face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Complex A™ Tretinoin Cream, USP (Emollient). Apply a pea-sized amount of cream to cover your entire face. You may feel a warmth or slight stinging when Complex A™ Tretinoin Cream, USP (Emollient) is first applied.

You must be especially careful when applying the cream to avoid your eyes, ears, nostrils, or mouth. Complex A™ Tretinoin Cream, USP (Emollient) may cause severe redness, itching, burning, stinging, and peeling if applied to these areas.

Using larger than necessary amounts of Complex A™ Tretinoin Cream, USP (Emollient) will not speed results and can cause an overdose. An overdose can result in red and peeling skin as well as some pain or discomfort.

You may use cosmetics after applying Complex A™ Tretinoin Cream, USP (Emollient). Make sure to clean your face thoroughly before applying Complex A™ Tretinoin Cream, USP (Emollient) again.

What Should I Avoid While Using Complex A™ Tretinoin Cream, USP (Emollient)?

Complex A™ Tretinoin Cream, USP (Emollient) increases your sensitivity to sunlight. Avoid sunlight as much as possible. Use protective clothing and a sunscreen with a minimum SPF of 15. Do not sunbathe or use sunlamps. If you are sensitive to sunlight or have a job that requires you to be out in the sun for long periods, you must use extreme caution.

While using Complex A™ Tretinoin Cream, USP (Emollient), avoid any products that can dry or irritate the skin. For example, avoid products applied to the skin that contain alcohol, spices, or lime. Also, avoid cleansers, hair removal, or other products that can irritate the skin.

What Are the Possible Side Effects of Complex A™ Tretinoin Cream, USP (Emollient)?

The most common side effects are skin reactions. Itching, red, and dry skin have been reported. So have burning, stinging, and peeling skin. These are most often mild and are most common when treatment is started.

How Can I Get Additional Information?

This leaflet summarizes the most important information about Complex A™ Tretinoin Cream, USP (Emollient). If you would like more information, talk to your doctor or other health care provider. There is also a leaflet written for health professionals that your pharmacist can provide for you.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO FDA AT 1-800-FDA-1088.

Applies to tretinoin topical: topical cream, topical gel/jelly, topical liquid, topical solution

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

Along with its needed effects, tretinoin topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking tretinoin topical:

• Burning feeling or stinging skin (severe)
• lightening of skin of treated area, unexpected
• peeling of skin (severe)
• redness of skin (severe)
• unusual dryness of skin (severe)

• Darkening of treated skin

Some side effects of tretinoin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning feeling, stinging, or tingling of skin (mild)lasting for a short time after first applying the medicine
• chapping or slight peeling of skin (mild)
• redness of skin (mild)
• unusual dryness of skin (mild)
• unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

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