Tretinoin

Retin-A Micro

RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

Renova

• RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.
• RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
• RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing.
• Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time.
• Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
• Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS).

Retin-A Micro

0.1% (1 mg of tretinoin per gram). Gel: 0.04%, 0.06%, 0.08%, and 0.1%

Renova

RENOVA ® (tretinoin cream), 0.02% is supplied in 20 g tube (NDC 0187-5150-20), 40 g tube (NDC 0187-5150-40), 60 g tube (NDC 0187-5150-60), 44 g pump (NDC 0187-5150-44).

Retin-A Micro

• For topical use only. Not for oral, ophthalmic, or intravaginal use.
• Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes.
• Apply a thin layer of RETIN-A MICRO to skin where acne lesions appear (cover the entire affected area) (0.04%, 0.06%, 0.08%, or 0.1%) once daily in the evening.

Renova

• 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.

Retin-A Micro

Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis.

Renova

(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.

Retin-A Micro

• Local Skin Irritation: RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging
• Initial Worsening of Inflammatory Acne Vulgaris: During the early weeks of RETIN-A MICRO treatment, an apparent exacerbation of inflammatory lesions may occur. If RETIN-A MICRO is tolerated, this should not be considered a reason to discontinue therapy.
• Photosensitivity: RETIN-A MICRO can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to UV light, including sunlight and sunlamps. Advise patients to use sunscreen (SPF ≥15) and sun-protective clothing if UV light exposure cannot be avoided. Avoid use on sunburn skin.

Renova

• 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.
• 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.

Retin-A Micro

None. The label states that there are no contraindications.

Renova

• 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.

Renova

• Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA (tretinoin cream) 0.02%...
• 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.

Retin-A Micro

Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).

Renova

Teratogenic Effects ORAL tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. It was teratogenic and fetotoxic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (42 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported.