Rx Item-Arazlo (tazarotene) Lotion 45GM Tube BY Bausch Health

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARAZLO safely and effectively. See full prescribing information for ARAZLO. ARAZLO�(tazarotene)lotion, for topical useInitial U.S. Approval: 1997 ----------------------------INDICATIONS AND USAGE ---------------------------- ARAZLO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1) ----------------------- DOSAGE AND ADMINISTRATION ----------------------- � Apply a thin layer of ARAZLO to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes. (2)� Not for oral, ophthalmic, or intravaginal use. (2) --------------------- DOSAGE FORMS AND STRENGTHS --------------------- Lotion, 0.045% (3) ------------------------------- CONTRAINDICATIONS ------------------------------- ARAZLO is contraindicated in pregnancy. (4, 8.1) ----------------------- WARNINGS AND PRECAUTIONS ----------------------- �Embryofetal Toxicity: May cause fetal harm when administered during pregnancy. Patients of childbearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use effective contraception during treatment. (5.1) �Skin Irritation: Pain, dryness, exfoliation, erythema, and pruritus may occur with use of ARAZLO. Avoid application to eczematous or sunburned skin. (5.2)�Photosensitivity and Risk for Sunburn: Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. Administer with caution if the patient is also taking drugs known to be photosensitizers. (5.3) ------------------------------ ADVERSE REACTIONS ------------------------------ The most common adverse reactions (occurring in ?1% of the ARAZLO group and greater than the vehicle group) were application site reactions; pain, dryness, exfoliation, erythema and pruritus. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 12/2019

Rx Item-Arazlo (tazarotene) Lotion 45GM
RX0187-2098-45

Rx Item-Arazlo (tazarotene) Lotion 45GM
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