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
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- Dispense ACANYA Gel with a 10-week expiration date.
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- Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
16.3 Storage and Handling
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- PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F).
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- PATIENT: Store at room temperature at or below 25°C (77°F).
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- Protect from freezing.
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- Store pump upright.
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- Keep out of the reach of children.
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- Keep container tightly closed.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
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- Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately.
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- ACANYA Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
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- 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.
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- 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
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Important information: ACANYA Gel is for use on skin only (topical use). Do not use ACANYA Gel in your mouth, eyes, or vagina. |
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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.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. |
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What should I avoid while using ACANYA Gel?
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What are possible side effects of ACANYA Gel? ACANYA Gel can cause serious side effects including:
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.
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?
Keep ACANYA Gel and all medicines out of the reach of children. |
General information about the safe and effective use of ACANYA Gel.
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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.
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- Apply ACANYA Gel to your face 1 time each day as prescribed.
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- Before you apply ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
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- 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.
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- One pea-sized amount of ACANYA Gel should be enough to cover your entire face.
- Figure 1
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- 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.
Figure 2
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- 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.
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- Wash your hands with soap and water after applying ACANYA Gel.
How should I store ACANYA Gel?
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- Store ACANYA Gel at room temperature at or below 77°F (25°C).
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- Do not freeze ACANYA Gel.
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- Throw away (discard) ACANYA Gel that has passed the expiration date.
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- Store pump upright.
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- 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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