Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to the face once daily, in the evening or as directed by the physician. The skin should be gently washed, rinsed with warm water, and patted dry before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use.

Gel, 1.2%/5%

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide.

The following adverse reaction is described in more detail in the Warnings and Precautions section of the label:

• Colitis [see Warnings and Precautions ( 5.1)].

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to slightly yellow, opaque, aqueous gel formulation.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

Clindamycin phosphate is C 18H 34ClN 2O 8PS. The structural formula for clindamycin phosphate is represented below:

Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-α-D- galacto-octopyranoside 2-(dihydrogen phosphate).

Benzoyl peroxide is C 14H 14O 4. It has the following structural formula:

Benzoyl Peroxide has a molecular weight of 242.23.

Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, edetate disodium, glycerin, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.

In five randomized, double-blind clinical trials of 1,319 subjects, 397 used Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 396 used benzoyl peroxide, 349 used clindamycin, and 177 used vehicle. Subjects were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily in the evening before retiring. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% applied once daily for 11 weeks was significantly more effective than vehicle, benzoyl peroxide, and clindamycin in the treatment of inflammatory lesions of moderate to moderately severe facial acne vulgaris in three of the five trials (Trials 1, 2, and 5).
Subjects were evaluated and acne lesions counted at each clinical visit at Weeks 2, 5, 8, 11. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at Week 11. Percent reductions in inflammatory lesion counts after treatment for 11 weeks in these 5 trials are shown in Table 2.

Table 2. Mean Percent Reduction in Inflammatory Lesion Counts

The group treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% showed greater overall improvement in the investigator's global assessment than the benzoyl peroxide, clindamycin, and vehicle groups in three of the five trials (Trials 1, 2, and 5).

Clinical trials have not adequately demonstrated the effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% versus benzoyl peroxide alone in the treatment of non-inflammatory lesions of acne.

16.1 How Supplied
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel.

NDC: 72162-2299-2: 45 g in a TUBE

16.2 Storage and Handling
Pharmacist:

Prior to Dispensing: Store in a cold place, preferably in a refrigerator, between 2°C and 8°C (36°F and 46°F). Do not freeze.
16.3 Dispensing Instructions for the Pharmacist
Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with a 60 day expiration date.
Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
Keep tube tightly closed.
Keep out of the reach of small children.

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

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.
• Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% 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.
• Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may bleach hair or colored fabric.
• Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause skin and facial hair to temporarily change color (yellow/orange) when used with topical sulfone products.

Manufactured by:

Encube Ethicals Pvt. Ltd.
Plot No. C-1, Madkaim Industrial Estate, Madkaim,
Post Mardol, Ponda, Goa-403 404, India.

Distributed by:

Encube Ethicals , Inc.
200 Meredith Avenue, Suite 101A
Durham, NC 27713 USA

PHARMACIST – DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

Read this Patient Information before you start using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a prescription medicine used on the skin (topical) to treat inflamed acne in people 12 years and older.

Who should not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% if you have:

• had an allergic reaction to clindamycin, lincomycin, benzoyl peroxide, or any of the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. See the end of this leaflet for a complete list of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.
• Crohn's disease or ulcerative colitis.
• had inflammation of the colon (colitis) with past antibiotic use.

What should I tell my healthcare provider before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, tell your healthcare provider about all of your medical conditions, including if you:

• plan to have surgery with general anesthesia.
• are sensitive to sunlight.
• are pregnant or plan to become pregnant.It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% passes into your breast milk. One of the medicines in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is clindamycin. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. You and your healthcare provider should decide if you will use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, herbal supplements, and skin products you use. Using other topical acne products may increase the irritation of your skin when used with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.

• Especially tell your healthcare provider if you take a medicine that contains erythromycin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should not be used with products that contain erythromycin.
• Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause skin and facial hair to temporarily change color (yellow or orange) when used with topical products that contain sulfones.

How should I use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

• Use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% exactly as your healthcare provider tells you to use it.
• Before you apply Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, wash your face gently with a mild soap, rinse with warm water, and pat the skin dry.
• Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to your face 1 time a day, in the evening or as directed by your healthcare provider. Wash your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.
• Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% in your mouth, eyes, nose, vagina, or on your lips. Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% on cuts or open wounds.

What should I avoid while using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

• 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. Sunscreen may also be used.
• Talk to your healthcare provider if you spend a lot of time in the sun.
• Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may bleach hair or colored fabric.

What are the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause serious side effects, including:

• Inflammation of the colon (colitis). Stop using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and call your healthcare provider right away if you have severe watery diarrhea, or bloody diarrhea.
• Allergic reactions. Stop using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and call your healthcare provider or 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

The most common side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% are skin reactions and may include redness, peeling, dryness, and burning. These are not all the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.

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 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

• Store Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% at room temperature up to 25°C (77°F). Do not freeze Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.
• The expiration date of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is 60 days from the date when you fill your prescription.
• Safely throw away expired Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%.
• Keep the tube tightly closed.

Keep Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and all medicines out of the reach of children.

General information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% for a condition for which it was not prescribed. Do not give Clindamycin Phosphate and Benzoyl PeroxideGel, 1.2%/5% to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your healthcare provider. You can also ask your pharmacist or healthcare provider for information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% that is written for health professionals.

For more information, call 1-833-285-4151.

What are the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%?

Active ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 5%

Inactive ingredients: carbomer homopolymer (type C), dimethicone, edetate disodium, glycerin, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide.

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

Manufactured by:

Encube Ethicals Pvt. Ltd.
Plot No. C-1, Madkaim Industrial Estate, Madkaim,
Post Mardol, Ponda, Goa-403 404, India.

Distributed by:

Encube Ethicals , Inc.
200 Meredith Avenue, Suite 101A
Durham, NC 27713 USA

Rev: 01

July 2020

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

Extended Label