Proctofoam

• Alaven Pharmaceutical LLC

• Meda Pharmaceuticals, Inc.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all.

You should not use this medication if you are allergic to pramoxine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs or any other numbing medicines.

FDA pregnancy category C. It is not known whether pramoxine topical will harm an unborn baby. Do not use this medication without medical advice if you are pregnant.

It is not known whether pramoxine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

Avoid getting this medication in your eyes or nose. If this does happen, rinse with water. Do not use pramoxine topical on deep skin wounds, blistered skin, severe burns, or large skin areas. Seek medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with pramoxine topical unless your doctor tells you to.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pramoxine topical and call your doctor at once if you have a serious side effect such as:

• any new redness or swelling where the medicine was applied; or

• severe pain, burning, or stinging where the medicine is applied.

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied pramoxine. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Proctofoam or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Proctofoam. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to pramoxine topical: topical aerosol, topical cream, topical lotion, topical ointment

Side effects include:

Local burning or stinging.