ARAZLO

1 Recommended Dose and Dosage Adjustment ARAZLO should be applied in a thin layer to the affected area once a day on clean and dry skin. In pediatric patients 10 to less than 12 years of age, it is recommended that the application be PrARAZLO™ Product Monograph Page 5 of 25 Protected B / Protégé B limited to the face only.

Health Canada has not authorized an indication in pediatric subjects less than 10 years of age (see 1 INDICATION; 7 WARNINGS AND PRECAUTIONS). Concomitant use with oxidizing agents, such as benzoyl peroxide should be avoided. g. one in the morning and the other in the evening).

4 Administration Apply a thin layer of ARAZLO once daily on affected areas and rub in gently. For face application, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion.

Wash hands after applying ARAZLO. If needed, use a moisturizer before or after the use of ARAZLO and allow sufficient time for the skin to dry between both applications. Avoid the eyes, mouth, paranasal creases, and mucous membranes.

If ARAZLO gets in or near eyes, rinse thoroughly with water. Treatment should be discontinued when control has been achieved. Treatment may be reinitiated as necessary. Intermittent use should be the least number of applications that will prevent recurrence of acne.

5 Missed Dose Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

1 Adverse Reaction Overview Across the clinical studies that contributed to the evaluation of safety for ARAZLO, the most frequently reported events were generally associated with application site reactions and other related, topical skin events.

Most events were mild or moderate in severity. Few events across studies were serious and none of the serious adverse events (SAEs) were considered by the investigator to be treatment related. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In 2 multicenter, randomized, double-blind, vehicle-controlled clinical trials, subjects age 9 years and older applied ARAZLO or vehicle once daily for 12 weeks.

The majority of subjects were white (74%) and female (66%). 8% were between 9 years to less than 12 years of age. Adverse reactions reported by ≥1% of subjects treated with ARAZLO and more frequently than subjects treated with vehicle are summarized in Table 2.

Most adverse reactions were mild to moderate in severity. 3% of the subjects treated with ARAZLO. 8% (22/779) of subjects discontinued ARAZLO because of TEAEs. 8) PrARAZLO™ Product Monograph Page 10 of 25 Protected B / Protégé B System Organ Classa Preferred Term ARAZLO (N=779) Vehicle Lotion (N=791) TEAE = treatment-emergent adverse event a Counts reflect numbers of subjects reporting one or more adverse events that map to MedDRA.

At each level of summarization (System Organ Class or Preferred Term) subjects are counted once. Counts reflect numbers of subjects reporting 1 or more TEAEs that map to system organ classes or preferred terms. At each level of summarization (system organ class or preferred term), subjects are counted once.

; 10 ACTION AND CLINICAL PHARMACOLOGY; 14 CLINICAL TRIALS). Safety and efficacy of ARAZLO in children below the age of 10 years has not been established. Therefore, Health Canada has not authorized an indication in pediatric patients less than 10 years of age.

4 Geriatrics). 2 CONTRAINDICATIONS ARAZLO (tazarotene lotion) is contraindicated in the following: • Patients who are hypersensitive to retinoic compounds or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Pregnant Women). • Topical retinoids should not be used in the presence of seborrheic dermatitis. 1 Recommended Dose and Dosage Adjustment ARAZLO should be applied in a thin layer to the affected area once a day on clean and dry skin.

In pediatric patients 10 to less than 12 years of age, it is recommended that the application be PrARAZLO™ Product Monograph Page 5 of 25 Protected B / Protégé B limited to the face only. Health Canada has not authorized an indication in pediatric subjects less than 10 years of age (see 1 INDICATION; 7 WARNINGS AND PRECAUTIONS).

Concomitant use with oxidizing agents, such as benzoyl peroxide should be avoided. g. one in the morning and the other in the evening). 4 Administration Apply a thin layer of ARAZLO once daily on affected areas and rub in gently. For face application, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face.

If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. Wash hands after applying ARAZLO. If needed, use a moisturizer before or after the use of ARAZLO and allow sufficient time for the skin to dry between both applications.

Avoid the eyes, mouth, paranasal creases, and mucous membranes. If ARAZLO gets in or near eyes, rinse thoroughly with water. Treatment should be discontinued when control has been achieved. Treatment may be reinitiated as necessary. Intermittent use should be the least number of applications that will prevent recurrence of acne.

ARAZLO (tazarotene lotion) is contraindicated in the following: • Patients who are hypersensitive to retinoic compounds or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Pregnant Women). • Topical retinoids should not be used in the presence of seborrheic dermatitis.