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Clindesse Cream is used for:

Treating vaginal infections caused by certain bacteria.

Clindesse Cream is a topical lincomycin antibiotic. It works by slowing the growth of certain bacteria.

Do NOT use Clindesse Cream if:

• you are allergic to any ingredient in Clindesse Cream or to lincomycin
• you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

Contact your doctor or health care provider right away if any of these apply to you.

Before using Clindesse Cream:

Some medical conditions may interact with Clindesse Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a gastrointestinal (bowel) disease or diarrhea

Some MEDICINES MAY INTERACT with Clindesse Cream. Because little, if any, of Clindesse Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clindesse Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Clindesse Cream:

Use Clindesse Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clindesse Cream is for vaginal use only.
• Wash your hands before and after using Clindesse Cream.
• Clindesse Cream comes with one prefilled applicator. Do not remove the tip from the applicator before using. Do not use the applicator if the tip has been removed. Do not warm the applicator before using.
• To use Clindesse Cream, hold the applicator firmly and pull the ring back to fully extend the plunger. Gently insert the applicator into the vagina as far as it will comfortably go. Push the plunger to release the cream. Remove the applicator from the vagina and throw it away.
• Only one dose of Clindesse Cream is required. If you forget to use Clindesse Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Clindesse Cream.

Important safety information:

• Avoid contact with the eyes. Burning and irritation can occur. If contact does occur, rinse the eye with large amounts of cool tap water.
• Do not have sexual intercourse or use other vaginal products, such as tampons or douches, while using Clindesse Cream.
• Use a sanitary napkin rather than a tampon to prevent staining of clothes and bed linens.
• This cream contains mineral oil that may weaken latex products such as condoms and diaphragms. Therefore, do not use these products within 5 days of using this product. They may not provide adequate birth control and you may become pregnant.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. This could be a symptom of a serious side effect requiring immediate medical attention.
• Be sure to use Clindesse Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Clindesse Cream may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clindesse Cream while you are pregnant. It is not known if Clindesse Cream is found in breast milk. If you are or will be breast-feeding while you use Clindesse Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Clindesse Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fungal infection; genital itching or burning; inflammation or pain; vaginal discharge.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood/mucus in stool; diarrhea; new or worsening vaginal or vulvar itching; painful sex; stomach cramps/pain; white vaginal discharge.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Clindesse Cream may be harmful if swallowed.

Store Clindesse Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly-closed container away from heat and light. Protect from freezing. Keep Clindesse Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Clindesse Cream, please talk with your doctor, pharmacist, or other health care provider.
• Clindesse Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Clindesse Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.