Uses of Pramoxine and Zinc Oxide Rectal Cream:

• It is used to treat signs of hemorrhoids or rectal irritation.

What do I need to tell my doctor BEFORE I take Pramoxine and Zinc Oxide Rectal Cream?

• If you have an allergy to pramoxine, zinc oxide, or any other part of pramoxine and zinc oxide rectal cream.
• If you are allergic to pramoxine and zinc oxide rectal cream; any part of pramoxine and zinc oxide rectal cream; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take pramoxine and zinc oxide rectal cream with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Pramoxine and Zinc Oxide Rectal Cream?

• Tell all of your health care providers that you take pramoxine and zinc oxide rectal cream. This includes your doctors, nurses, pharmacists, and dentists.
• If signs get worse or last for more than 7 days, talk with the doctor.
• This medicine may cause harm if swallowed. If pramoxine and zinc oxide rectal cream is swallowed, call a doctor or poison control center right away.
• Do not give pramoxine and zinc oxide rectal cream to a child younger than 12 years old without first checking with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using pramoxine and zinc oxide rectal cream while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Pramoxine and Zinc Oxide Rectal Cream) best taken?

Use pramoxine and zinc oxide rectal cream as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use rectal cream rectally.
• Do not take pramoxine and zinc oxide rectal cream by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash hands before and after use.
• Wash affected skin and pat dry.
• Put a thin layer on the affected part.
• Do not put pramoxine and zinc oxide rectal cream into the rectum by using your fingers or any type of applicator. Follow what the doctor has told you to do.

What do I do if I miss a dose?

• This medicine is used on an as needed basis. Do not use more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Redness.
• Rectal irritation.
• Swelling.
• Bleeding from rectum or rectal pain.

What are some other side effects of Pramoxine and Zinc Oxide Rectal Cream?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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.

How do I store and/or throw out Pramoxine and Zinc Oxide Rectal Cream?

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about pramoxine and zinc oxide rectal cream, 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.