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ACANYA- clindamycin phosphate and benzoyl peroxide gel


  1. Patient Information
  2. Do Not Use Acanya Gel If You Have:
  3. Before Using Acanya Gel, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  4. How Should I Use Acanya Gel?
  5. Acanya Gel Can Cause Serious Side Effects Including:
  6. Common Side Effects With Acanya Gel Include:
  7. How Should I Store Acanya Gel?
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. Manufactured For:
  11. Revised: 10/2016document Id:

Patient Information 

ACANYA Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older. ACANYA Gel contains clindamycin phosphate and benzoyl peroxide.

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: 

Crohn's disease
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 one of these conditions.

Before Using Acanya Gel, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

have any allergies.
have any other medical conditions
are pregnant or planning to become pregnant.It is not known if ACANYA Gel will harm your unborn baby.
are breastfeeding or plan to breast-feed.It is not known if ACANYA Gel passes into your breast milk. One of the medicines in ACANYA Gel contains clindamycin. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. You and your doctor should decide whether you will use ACANYA Gel while breast-feeding.

Tell your doctor about all the medicines and skin products you use.Especially tell your doctor if you will have surgery with general anesthesia. One of the medicines in ACANYA Gel (clindamycin) can affect how certain medicines work when used in general anesthesia.

ACANYA Gel should not be used with products that contain erythromycin.
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 prescribed.
Your doctor will tell you how long to use ACANYA Gel.
Throw away (discard) any unused ACANYA Gel.

Instructions for applying ACANYA Gel

Apply ACANYA Gel to your face one time each day as prescribed.
1.
Before you apply ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
2.
To apply ACANYA Gel to your face, use the pump to dispense one pea-sized amount of ACANYA Gel onto your fingertip.

Limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher. Your doctor can give you more information about why this is important.
Do not wash your face more than 2 to 3 times a day. Washing your face too often or scrubbing it may make your acne worse.
Avoid getting ACANYA Gel in your hair or on colored fabric. ACANYA Gel may bleach hair or colored fabric.

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 watery diarrhea, or bloody diarrhea.
Allergic reactions.Stop using ACANYA Gel, call your doctor and get help right away if you have any of the following symptoms:
o
severe itching
o
swelling of your face, eyes, lips, tongue or throat
o
trouble breathing

Common Side Effects With Acanya Gel Include: 

Skin irritation.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 the possible side effects with ACANYA Gel. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Valeant Pharmaceuticals North America LLC, at 1-800-321-4576.

How Should I Store Acanya Gel? 

Store ACANYA Gel at room temperature at or below 25 C (77 F).
The expiration date of ACANYA Gel is 10 weeks from the date you fill your prescription.
Safely throw away expired ACANYA Gel.
Do not freeze.
Keep the container tightly closed.

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

General information about ACANYA Gel

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. 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.

This leaflet summarizes the most important information about ACANYA Gel. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about ACANYA Gel that is written for healthcare professionals.

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

Active Ingredients: 

clindamycin phosphate 1.2% and benzoyl peroxide 2.5%

Inactive Ingredients: 

purified water, carbomer 980, propylene glycol, and potassium hydroxide

Manufactured For: 

Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA


By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada

U.S. Patents 8,288,434; 8,663,699; 8,895,070 and 9,078,870

Acanya is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.

Valeant Pharmaceuticals North America LLC

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

Revised 10/2016

9387202 50104737C



PRINCIPAL DISPLAY PANEL - 50 gram Pump Label

NDC13548-132-50

Acanya
(Clindamycin Phosphate and
Benzoyl Peroxide) Gel, 1.2%/2.5%

Rx only

FOR TOPICAL USE ONLY

One premixed 50-gram pump dispenser

carton.jpg
ACANYA
clindamycin phosphate and benzoyl peroxide gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13548-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clindamycin Phosphate(UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C)Clindamycin10 mg in 1 g
Benzoyl Peroxide(UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)Benzoyl Peroxide25 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Water(UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
propylene glycol(UNII: 6DC9Q167V3)
potassium hydroxide(UNII: WZH3C48M4T)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13548-132-501 in 1 CARTON07/26/2010
150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05081907/26/2010
Labeler -Valent Pharmaceuticals North America (010977972)
Registrant -Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Valeant Pharmaceuticals International, Inc245141858MANUFACTURE(13548-132)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmaceuticals Limited Canada248761249MANUFACTURE(13548-132)

Revised: 10/2016document Id: 

f0ecc3ca-ee50-4cd7-87a0-bd931dc93604Set id: 3dcd2c96-72b1-4a9f-b65c-08198d63b7dfVersion: 10Effective Time: 20161027Valent Pharmaceuticals North America



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