Clindamycin Foam

Clindamycin Phosphate Foam, 1% is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.

White to off-white thermolabile foam. Each gram of Clindamycin Phosphate Foam, 1% contains, as dispensed, 12 mg (1.2%) of clindamycin phosphate, equivalent to 10 mg (1%) of clindamycin.

Erythromycin

Clindamycin Phosphate Foam, 1% should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its clindamycin component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

Neuromuscular Blocking Agents

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Phosphate Foam, 1% should be used with caution in patients receiving such agents.

Pregnancy

Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate foam, 1%. Clindamycin Phosphate Foam, 1% should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus.

Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride. These studies revealed no evidence of fetal harm.

The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84 fold higher, and for a mouse 42 fold higher, than the anticipated human dose of clindamycin phosphate from clindamycin phosphate foam, 1% based on a mg/m2 comparison.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of Clindamycin Phosphate Foam, 1%. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

If used during lactation and Clindamycin Phosphate Foam, 1% is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

Pediatric Use

Safety and effectiveness of clindamycin phosphate foam, 1% in children under the age of 12 have not been studied.

Geriatric Use

The clinical study with clindamycin phosphate foam, 1% did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

How Supplied

Clindamycin Phosphate Foam, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is white to off-white in color and thermolabile.

It is available in the following sizes:

• 100 gram aerosol can - NDC 45802-660-33 • 50 gram aerosol can - NDC 45802-660-32

Storage and Handling

Store at 20-25°C (68-77°F) [see USP controlled room temperature].

Flammable. Avoid fire, flame or smoking during and immediately following application.

Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C).

Keep out of reach of children.

See FDA-Approved patient labeling (Patient Information).

Instructions for Use

• Patients should be advised to wash their skin with mild soap and allow it to dry before applying Clindamycin Phosphate Foam, 1%. • Patients should use enough Clindamycin Phosphate Foam, 1% to cover the face and to apply once daily. • Patients should dispense Clindamycin Phosphate Foam, 1% directly into the cap or onto a cool surface. • Patients should wash their hands after applying Clindamycin Phosphate Foam, 1%.

Skin Irritation

Clindamycin Phosphate Foam, 1% may cause irritation such as erythema, scaling, itching, burning, or stinging. Patients should be advised to discontinue use if excessive irritancy or dermatitis occur.

Colitis

In the event a patient treated with Clindamycin Phosphate Foam, 1% experiences severe diarrhea or gastrointestinal discomfort, Clindamycin Phosphate Foam, 1% should be discontinued and a physician should be contacted.

Made in Israel

Manufactured by Perrigo

Yeruham 80500, Israel

Rev 10-13

Pharmacist-Detach here and Give Instructions to Patient

4T500 RC J3

Clindamycin Phosphate Foam, 1%

Important: For skin use only. Do not use Clindamycin Phosphate Foam, 1% in your eyes, mouth or vagina.

Read the Patient Information that comes with Clindamycin Phosphate Foam, 1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

What is Clindamycin Phosphate Foam, 1%?

Clindamycin Phosphate Foam, 1% is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.

It is not known if Clindamycin Phosphate Foam, 1% is safe and effective in children under 12 years of age.

Who should not use Clindamycin Phosphate Foam, 1%?

Do not use Clindamycin Phosphate Foam, 1% if you:

• have Crohn’s disease • have ulcerative colitis • 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, 1%? Before you use Clindamycin Phosphate Foam, 1%, tell your doctor if you:

• have a history of eczema • are planning to have surgery. Clindamycin Phosphate Foam, 1% may affect how certain medicines work that may be given during surgery. • have any other medical conditions • are pregnant or planning to become pregnant. It is not known if Clindamycin Phosphate Foam, 1% may harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Clindamycin Phosphate Foam, 1% passes through your breast milk.

You and your doctor should decide if you will use Clindamycin Phosphate Foam, 1% or breastfeed. If you use Clindamycin Phosphate Foam, 1% while breastfeeding and Clindamycin Phosphate Foam, 1% is applied on the chest, take care to avoid getting Clindamycin Phosphate Foam, 1% into your baby’s mouth.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Clindamycin Phosphate Foam, 1% may affect the way other medicines work and other medicines may affect how Clindamycin Phosphate Foam, 1% works.

Especially tell your doctor if you take 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, 1%?

• Clindamycin Phosphate Foam, 1% is for use on the skin only. Do not get Clindamycin Phosphate Foam, 1% in your eyes, mouth or vagina. • Use Clindamycin Phosphate Foam, 1% exactly as your doctor tells you to use it. See the “Instructions for Applying Clindamycin Phosphate Foam, 1%” below. • Apply Clindamycin Phosphate Foam, 1% 1 time a day. • Wash your skin with mild soap and water and dry before applying Clindamycin Phosphate Foam, 1%. • Do not dispense Clindamycin Phosphate Foam, 1% directly onto your hands or face, because the foam will begin to melt on contact with warm skin. • Wash your hands after applying Clindamycin Phosphate Foam, 1%.

Throw away any of the unused medicine that you dispensed out of the can.

What should I avoid while using Clindamycin Phosphate Foam, 1%?

• Clindamycin Phosphate Foam, 1% is flammable. Avoid fire, flames, or smoking during and right after you apply Clindamycin Phosphate Foam, 1% to your skin. • Avoid getting Clindamycin Phosphate Foam, 1% in or near your eyes, mouth, lips, or broken skin. If you get Clindamycin Phosphate Foam, 1% in your eyes, mouth, on lips or broken skin, rinse well with water.

What are possible side effects with Clindamycin Phosphate Foam, 1%? Clindamycin Phosphate Foam, 1% can cause serious side effects including:

• Inflammation of the colon (colitis). Clindamycin can cause severe colitis that may lead to death. Stop using Clindamycin Phosphate Foam, 1% and call your doctor right away if you have severe watery diarrhea, or bloody diarrhea.

The most common side effects of Clindamycin Phosphate Foam, 1% include:

• Skin irritation. Clindamycin Phosphate Foam, 1% may cause skin irritation such as burning, itching, or dryness. Stop using Clindamycin Phosphate Foam, 1% and talk with your doctor if you develop excessive skin irritation. • Headache.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the side effects of Clindamycin Phosphate Foam, 1%. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Perrigo at 1-866-634-9120.

How should I store Clindamycin Phosphate Foam, 1%?

• Store Clindamycin Phosphate Foam, 1% at room temperature between 68°F to 77°F (20°C to 25°C). • Keep Clindamycin Phosphate Foam, 1% away from heat. Never throw the can into a fire, even if the can is empty. • Do not store Clindamycin Phosphate Foam, 1% at temperatures above 120°F (49°C). • Do not break through (puncture) the Clindamycin Phosphate Foam, 1% can.

Keep Clindamycin Phosphate Foam, 1% and all medicines out of the reach of children.

General information about the safe and effective use of Clindamycin Phosphate Foam, 1%:

Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use Clindamycin Phosphate Foam, 1% for a condition for which it was not prescribed. Do not give Clindamycin Phosphate Foam, 1% to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Clindamycin Phosphate Foam, 1%. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Clindamycin Phosphate Foam, 1% that is written for health professionals.

What are the ingredients in Clindamycin Phosphate Foam, 1%?

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.

Made in Israel

Manufactured by Perrigo

Yeruham 80500, Israel

Rev 10-13

Pharmacist-Detach here and Give Instructions to Patient

4T500 RC J3

Rx Only

Clindamycin Phosphate Foam, 1%

Clindamycin Phosphate Foam, 1% Carton Image 1

Clindamycin Phosphate Foam, 1% Carton Image 2