* Indications: & & Adapalene gel is indicated for the topical treatment of moderately severe acne vulgaris. * Dosage and administration: & & Adapalene gel should be applied to the affected areas of the skin, once daily at night time, & & avoiding the eyes and lips. & & – The skin should be cleaned and dried before the application of the gel. & & – A thin film of the gel should be applied to the skin areas where acne lesions appear, using & & enough to cover the entire affected areas lightly. & & – A mild transitory sensation of warmth or slightly stinging may occur shortly after the application & & of Adapalene gel. & & – Therapeutic results should be noticed after 8 to 12 weeks of treatment. * Warnings and precautions: & & – Certain cutaneous signs such as erythema, dryness, scaling, burning, or pruritus may & & appear with the use of Adapalene gel. Depending on the severity of these side effects, & & patients should be instructed to reduce the frequency of application or discontinue its use. & & In any case, if a severity reaction or chemical irritation occurs, the use of the gel should & & be discontinued. & & – Avoid contact with eyes, lips, angles of the nose, and mucous membranes. In case of & & accidental exposure, wash well with warm water. & & – Moisturizers may be used if necessary, however, avoid products containing alpha-hydroxy & & glycolic acid. & & – The product should not be applied to cuts, abrasions or sun burned skin. The patient & & should wait for complete recovery before continuing administration. & & – Exposure to sunlight should be minimized during application of Adapalene. Sunscreens && & & protective clothing over treated areas should be recommended when exposure cannot be & & avoided. & & – Safety for use for children under the age of 12 has not been established. & & – The gel should be applied at night. & & – The gel is for topical application only && not for ophthlamic, oral or intravaginal use. & & – During the early weeks of therapy, an apparent exacerbation of acne may occur due to & & the action of the medication on previously unseen lesions && should not be considered a & & reason to discontinue therapy. * Contraindications: & & This product should not be administered to individuals who are hypersensitive to Adapalene & & or any of the components in the gel vehicle. * Pregnancy and lactation: & & – Adapalene gel should be used during pregnancy only if the potential benefit justifies the potential & & risk to the fetus. & & – It is not known that Adapalene is excreted in human milk, so caution should be exercised when & & Adapalene gel is administered to a nursing woman.