Prescription Drug Information: Acanya (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ACANYA Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as:

NDC 13548-132-50 50 g pump

16.2 Dispensing Instructions for the Pharmacist

Dispense ACANYA Gel with a 10-week expiration date.
Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”

16.3 Storage and Handling

PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F).
PATIENT: Store at room temperature at or below 25°C (77°F).
Protect from freezing.
Store pump upright.
Keep out of the reach of children.
Keep container tightly closed.

17 PATIENT COUNSELING INFORMATION

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

Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
ACANYA Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.
ACANYA Gel may bleach hair or colored fabric.

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

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

U.S. Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918

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

© 2020 Bausch Health Companies Inc. or its affiliates

9387203

Patient Package Insert

PATIENT INFORMATION

ACANYA® (AH-CAN΄-YAH) (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/2.5%

Important information: ACANYA Gel is for use on skin only (topical use). Do not use ACANYA Gel in your mouth, eyes, or vagina.

What is ACANYA Gel?
ACANYA Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.
It is not known if ACANYA Gel is safe and effective for use longer than 12 weeks.
It is not known if ACANYA Gel is safe and effective in children under 12 years of age.
Do not use ACANYA Gel if you have:
had an allergic reaction to clindamycin, benzoyl peroxide, lincomycin or any of the ingredients in ACANYA Gel. See the end of this leaflet for a complete list of ingredients in ACANYA Gel.
Crohn’s disease or ulcerative colitis.
had inflammation of the colon (colitis), or severe diarrhea with past antibiotic use.
Talk with your doctor if you are not sure if you have any of the conditions listed above.
Before using ACANYA Gel, tell your doctor about all of your medical conditions, including if you:
plan to have surgery. ACANYA Gel may affect how certain medicines work that may be given during
surgery.
are pregnant or plan to become pregnant. It is not known if ACANYA Gel will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ACANYA Gel passes into your breast milk. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. Talk to your doctor about the best way to feed your baby during treatment with ACANYA Gel.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. ACANYA Gel may affect the way other medicines work and other medicines may affect how ACANYA Gel works.

Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. ACANYA Gel should not be used with products that contain erythromycin.
Tell your doctor about any skin products you use. Other skin and topical acne products may increase the irritation of your skin when used with ACANYA Gel.

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

How should I use ACANYA Gel?
Use ACANYA Gel exactly as your doctor tells you to use it. See the detailed “Instructions for Use” for directions about how to apply ACANYA Gel.
Your doctor will tell you how long to use ACANYA Gel.
Apply ACANYA Gel to your face 1 time each day.

What should I avoid while using ACANYA Gel?

Limit your time in sunlight. You should avoid using tanning beds or sunlamps during treatment with ACANYA Gel. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and use sunscreen to cover the treated areas.
Avoid getting ACANYA Gel in your hair or on colored fabric. ACANYA Gel may bleach hair or colored fabric.

What are possible side effects of ACANYA Gel?

ACANYA Gel can cause serious side effects including:

Inflammation of the colon (colitis). Stop using ACANYA Gel and call your doctor right away if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and within several weeks after treatment with ACANYA Gel.
Allergic reactions. Stop using ACANYA Gel, call your doctor and get help right away if you have any of the following symptoms during treatment with ACANYA Gel:
o
severe itching
o
swelling of your face, eyes, lips, tongue or throat
o
trouble breathing

The most common side effects of ACANYA Gel include application site pain, application site irritation including redness, itching, burning, and stinging. Stop using ACANYA Gel and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects with ACANYA Gel.

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 ACANYA Gel?

Store ACANYA Gel at room temperature at or below 77°F (25°C).
Do not freeze ACANYA Gel.
Throw away (discard) ACANYA Gel that has passed the expiration date.
Store pump upright.
Keep the container tightly closed.

Keep ACANYA Gel and all medicines out of the reach of children.

General information about the safe and effective use of ACANYA Gel.

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

What are the ingredients in ACANYA Gel?

Active Ingredients: clindamycin phosphate and benzoyl peroxide

Inactive Ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water

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

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

U.S. Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918

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

© 2020 Bausch Health Companies Inc. or its affiliates

For more information about ACANYA Gel, call 1-800-321-4576.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 09/2020

9387203

Instructions for Use

INSTRUCTIONS FOR USE

ACANYA® (AH-CAN΄-YAH)(clindamycin phosphate and benzoyl peroxide) gel, 1.2%/2.5%

Important Information: ACANYA Gel is for use on skin only (topical use). ACANYA Gel is not for use in your mouth, eyes or vagina.

Read this Instructions for Use before you start using ACANYA Gel and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Apply ACANYA Gel to your face 1 time each day as prescribed.
Before you apply ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
To apply ACANYA Gel to your face, use the pump to dispense one pea-sized amount of ACANYA Gel onto your fingertip. See Figure 1.
One pea-sized amount of ACANYA Gel should be enough to cover your entire face.
figure1
(click image for full-size original)
Figure 1
Dot the one pea-sized amount of ACANYA Gel onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2.
figure2
(click image for full-size original)

Figure 2

Spread the gel over your face and gently rub it in. It is important to spread the gel over your entire face. If your doctor tells you to put ACANYA Gel on other areas of your skin with acne, be sure to ask how much you should use.
Wash your hands with soap and water after applying ACANYA Gel.

How should I store ACANYA Gel?

Store ACANYA Gel at room temperature at or below 77°F (25°C).
Do not freeze ACANYA Gel.
Throw away (discard) ACANYA Gel that has passed the expiration date.
Store pump upright.
Keep the container tightly closed.

Keep ACANYA Gel and all medicines out of the reach of children.

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

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

U.S. Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918

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

© 2020 Bausch Health Companies Inc. or its affiliates

The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Issued: 09/2020

9387203

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