Clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.

Clindamycin phosphate foam is for topical use only, and not for oral, ophthalmic or intravaginal use.

Apply clindamycin phosphate foam once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area.

If there has been no improvement after 6 to 8 weeks or if the condition becomes worse, treatment should be discontinued.

The contents of clindamycin phosphate foam are flammable; avoid fire, flame and/or smoking during and immediately following application.

Clindamycin phosphate foam is a white to off-white thermolabile foam. Clindamycin phosphate foam, 1% contains 10 mg of clindamycin as clindamycin phosphate, USP per gram.

Clindamycin phosphate foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis).

Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate.

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.

The chemical name for clindamycin phosphate 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). The structural formula for clindamycin phosphate is represented below:

Molecular Formula: C18H34CIN2O8PS           Molecular Weight: 504.97 g/mol

Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

In one multicenter, randomized, double-blind, vehicle-controlled clinical trial, subjects with mild to moderate acne vulgaris used clindamycin phosphate foam or the vehicle foam once daily for twelve weeks. Treatment response, defined as the proportion of subjects clear or almost clear, based on the Investigator Static Global Assessment (ISGA), and the mean percent reductions in lesion counts at the end of treatment in this study are shown in Table 2.

Table 2: Efficacy Results at Week 12

*P<0.05

See FDA-Approved patient labeling (Patient Information).

17.1 Instructions for Use

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Patients should be advised to wash their skin with mild soap and allow it to dry before applying clindamycin phosphate foam.

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Patients should use enough clindamycin phosphate foam to cover the face and to apply once daily.

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Patients should dispense clindamycin phosphate foam directly into the cap or onto a cool surface.

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Patients should wash their hands after applying clindamycin phosphate foam.

17.2 Skin Irritation

Clindamycin phosphate foam may cause irritation such as erythema, scaling, itching, burning, or stinging. Patients should be advised to discontinue use if excessive irritancy or dermatitis occur.

17.3 Colitis

In the event a patient treated with clindamycin phosphate foam experiences severe diarrhea or gastrointestinal discomfort, clindamycin phosphate foam should be discontinued and a physician should be contacted.

Manufactured by Padagis
Yeruham, Israel

Distributed By Padagis
Allegan, MI 49010

www.padagis.com

Rev 02-22

4T500 RC J5

Pharmacist-Detach here and Give Instructions to Patient

Patient Information

Clindamycin Phosphate (klin-da-MYE-sin fos-fate) Foam, 1%

Important Information: Clindamycin phosphate foam is for use on the skin only. Do not use clindamycin phosphate foam in your eyes, mouth or vagina.

What is clindamycin phosphate foam?

Clindamycin phosphate foam is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older.

It is not known if clindamycin phosphate foam is safe and effective in children under 12 years of age.

Who should not use clindamycin phosphate foam?
Do not use clindamycin phosphate foam if you:

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have Crohn’s disease

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have ulcerative colitis

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have had inflammation of the colon (colitis) or severe diarrhea with past antibiotic use

Tell your doctor if you are not sure if you have any of the conditions listed above.

What should I tell my doctor before using clindamycin phosphate foam?
Before using clindamycin phosphate foam, tell your doctor about all of your medical conditions, including if you:

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have or have had bowel problems (such as Crohn’s disease, ulcerative colitis, colitis)

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have or have had eczema or other skin problems

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are planning to have surgery. Clindamycin phosphate foam may affect how certain medicines work that may be given during surgery.

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are pregnant or plan to become pregnant. It is not known if clindamycin phosphate foam may harm your unborn baby.

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are breastfeeding or plan to breastfeed. It is not known if clindamycin phosphate passes into your breast milk. Talk to your doctor about using clindamycin phosphate foam while breastfeeding. If you use clindamycin phosphate foam while breastfeeding and clindamycin phosphate foam is applied on the chest, take care to avoid getting clindamycin phosphate foam into your baby’s mouth.

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

Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin.

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

How should I use clindamycin phosphate foam?

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Use clindamycin phosphate foam exactly as your doctor tells you to use it. See the detailed “Instructions for Use” for directions about how to apply clindamycin phosphate foam correctly.

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Wash your skin with mild soap and water and dry before applying clindamycin phosphate foam.

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Apply clindamycin phosphate foam 1 time each day to the affected skin area. You should apply enough clindamycin phosphate foam to cover the entire affected area.

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Dispense clindamycin phosphate foam directly into the cap. Do not dispense clindamycin phosphate foam directly onto your hands or face, because the foam will begin to melt on contact with warm skin.

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Wash your hands after applying clindamycin phosphate foam.

What should I avoid while using clindamycin phosphate foam?

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Clindamycin phosphate foam is flammable. Avoid fire, flames, or smoking during and right after you apply clindamycin phosphate foam to your skin.

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Avoid getting clindamycin phosphate foam in or near your eyes, mouth, lips, or broken skin. If you get clindamycin phosphate foam in your eyes, mouth, on lips or broken skin, rinse well with water.

What are possible side effects with clindamycin phosphate foam?
Clindamycin phosphate foam may cause serious side effects, including:

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Inflammation of the colon (colitis). Diarrhea, bloody diarrhea, and colitis has happened in people who use clindamycin phosphate foam. Stop using clindamycin phosphate foam and call your doctor right away if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and for several weeks after treatment, with clindamycin phosphate foam.

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Skin irritation. Stop using clindamycin phosphate foam and call your doctor if you develop skin irritation during treatment with clindamycin phosphate foam.

The most common side effects of clindamycin phosphate foam include headache and application site reactions (including burning, itching, and dryness).

These are not all the possible side effects of clindamycin phosphate foam.

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 foam?

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Store clindamycin phosphate foam at room temperature between 68°F to 77°F (20°C to 25°C).

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Keep clindamycin phosphate foam away from heat. Never throw the can into a fire, even if the can is empty.

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Do not store clindamycin phosphate foam at temperatures above 120°F (49°C).

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Do not break through (puncture) the clindamycin phosphate foam can.

Keep clindamycin phosphate foam and all medicines out of the reach of children.

General information about the safe and effective use of clindamycin phosphate foam.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use clindamycin phosphate foam for a condition for which it was not prescribed. Do not give clindamycin phosphate foam to other people, even if they have the same symptoms you have. It may harm them.

You can also ask your pharmacist or doctor for information about clindamycin phosphate foam that is written for health professionals.

What are the ingredients in clindamycin phosphate foam?

Active ingredient: clindamycin phosphate

Inactive ingredients: cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol. The can is pressurized with a hydrocarbon (propane/butane) propellant.

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

Instructions for Use

Clindamycin Phosphate (klin-da-MYE-sin fos-fate) Foam, 1%

Important Information: Clindamycin phosphate foam is for use on the skin only. Do not use clindamycin phosphate foam in your eyes, mouth or vagina.

	Step 1: Remove the clear cap from the clindamycin phosphate foam can.
	Step 2: Hold the can upright and firmly press the nozzle to dispense clindamycin phosphate foam into the clear cap.
	• Dispense enough clindamycin phosphate foam to cover the entire affected area.
	• If the can seems warm or the foam seems runny, run the can under cold water.
	Step 3: Pick up small amounts of clindamycin phosphate foam with your fingertips and gently rub the foam into the affected area until the foam disappears. Step 4: Wash your hands after applying clindamycin phosphate foam. • Throw away any of the unused medicine that you dispensed out of the can.

How should I store clindamycin phosphate foam?

•

Store clindamycin phosphate foam at room temperature between 68°F to 77°F (20°C to 25°C).

•

Keep clindamycin phosphate foam away from heat. Never throw the can into a fire, even if the can is empty.

•

Do not store clindamycin phosphate foam at temperatures above 120°F (49°C).

•

Do not break through (puncture) the clindamycin phosphate foam can.

Keep clindamycin phosphate foam and all medicines out of the reach of children.

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

Manufactured by
Padagis
Yeruham, Israel

Distributed By
Padagis
Allegan, MI 49010

www.padagis.com

Rev 02-22

4T500 RC J5

NDC 45802-660-32

Rx Only

Clindamycin Phosphate Foam, 1%

50g

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