Arazlo (Page 4 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

ARAZLO (tazarotene) Lotion, 0.045% is a white to off-white lotion supplied in a white aluminum tube as follows:

45 g (NDC 0187-2098-45)

Storage and Handling Conditions

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Embryofetal Toxicity

Inform patients of childbearing potential of the potential risk to a fetus. To avoid pregnancy, advise these patients to use effective contraception during treatment with ARAZLO. Advise patients to discontinue the medication if pregnant and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4.1),Warnings and Precautions (5.1), and Use in Specific Populations (8.1), (8.3)].

Lactation

Advise patients to use ARAZLO for the shortest duration possible while breastfeeding. Advise breastfeeding patients not to apply ARAZLO directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].

Skin Irritation

Advise patients to avoid applying ARAZLO to eczematous or sunburned skin. If undue irritation occurs, reduce frequency of application, temporarily interrupt treatment, or discontinue use. Treatment may be resumed once irritation subsides [see Warnings and Precautions (5.2)].

Photosensitivity and Risk of Sunburn

Advise patients to minimize exposure to sunlight and sunlamps; recommend the use of sunscreen products and protective apparel (e.g., wide-brimmed hat) when sun exposure cannot be avoided. Advise patients to avoid using ARAZLO if also taking other medicines that may increase sensitivity to sunlight [see Warnings and Precautions (5.3)].

Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.Laval, Quebec H7L 4A8, Canada

ARAZLO is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2021 Bausch Health Companies Inc. or its affiliates

9701201

Patient Information

PATIENT INFORMATION ARAZLO® (ah-RAZ-low) (tazarotene) lotion, for topical use

Important information: ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina.

What is the most important information I should know about ARAZLO?
ARAZLO may cause birth defects if used during pregnancy.
You must not be pregnant when you start using ARAZLO or become pregnant during treatment with ARAZLO.
For people who are able to get pregnant:
Your healthcare provider should order a pregnancy test for you within 2 weeks before you begin treatment with ARAZLO to be sure that you are not pregnant. Your healthcare provider will decide when to do the test.
Begin treatment with ARAZLO during a normal menstrual period.
Use an effective form of birth control (contraception) during treatment with ARAZLO. Talk with your healthcare provider about birth control options that may be used to prevent pregnancy during treatment with ARAZLO.
Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment with ARAZLO.

What is ARAZLO?

ARAZLO is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne vulgaris.

It is not known if ARAZLO is safe and effective in children under 9 years of age.

Do not use ARAZLO if you are pregnant or plan to become pregnant. See, “What is the most important information I should know about ARAZLO?” at the beginning of this leaflet.

Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:

have eczema or any other skin problems
are breastfeeding or plan to breastfeed. It is not known if ARAZLO passes into your breast milk. If you use ARAZLO while breastfeeding, use ARAZLO for the shortest time needed. Do not apply ARAZLO directly to the nipple and the areola to avoid your child being exposed to the medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight. Ask your healthcare provider for a list of medicines if you are not sure.

Especially tell your healthcare provider about any medicines (such as benzoyl peroxide) used on your skin or cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I use ARAZLO?

Use ARAZLO exactly as your healthcare provider tells you to use it.
Apply a thin layer of ARAZLO to cover the affected areas 1 time each day.
If you use other medicines on your skin such as benzoyl peroxide during treatment with ARAZLO, you should apply one in the morning and one in the evening to separate the application time.
Do not get ARAZLO in your eyes, the corners of your nose, or in your mouth. If ARAZLO gets in your eyes, rinse them well with water. Call your healthcare provider or get medical help if you have eye irritation that does not go away.
Wash your hands after applying ARAZLO.
What should I avoid during treatment with ARAZLO?
1.
Avoid sunlight, including sunlamps during treatment with ARAZLO. ARAZLO can make you more sensitive to the sun, and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen and wear a wide-brimmed hat and clothes that cover your skin if you have to be in sunlight.
2.
Avoid using cosmetics or topical medicines that may make your skin more sensitive to sunlight or make your skin dry.
3.
Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.

What are the possible side effects of ARAZLO?

ARAZLO may cause serious side effects, including:

See, “What is the most important information I should know about ARAZLO?”
Skin irritation. ARAZLO may cause application site skin pain, dryness, flaking or peeling, redness, and itching. Tell your healthcare provider if you develop any skin irritation during treatment with ARAZLO. If you develop any of these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you apply ARAZLO, or completely stop treatment with ARAZLO. Also, wind or cold weather may be more irritating to your skin during treatment with ARAZLO.
Sensitivity to sunlight and risk of sunburn. See, “What should I avoid during treatment with ARAZLO?”
The most common side effects of ARAZLO include skin pain, dryness, peeling, redness, and itching.

These are not all the possible side effects of ARAZLO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ARAZLO?

Store ARAZLO at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze.

Keep ARAZLO and all medicines out of the reach of children.

General information about the safe and effective use of ARAZLO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ARAZLO for a condition for which it was not prescribed. Do not give ARAZLO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ARAZLO that is written for health professionals.

What are the ingredients in ARAZLO?

Active ingredient: tazarotene

Inactive ingredients: carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

ARAZLO is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2021 Bausch Health Companies Inc. or its affiliates

For more information, call 1-800-321-4576.

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 05/2021
9701201

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