Brand Name(s):

Fleet^® Pain-Relief
Itch-X^®
PrameGel^®
Prax^®
Tronolane^®
Epifoam^® (as a combination product containing Hydrocortisone, Pramoxine)
Pramosone^® (as a combination product containing Hydrocortisone, Pramoxine)
Proctofoam^® (as a combination product containing Hydrocortisone, Pramoxine)

WHY is this medicine prescribed?

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

HOW should this medicine be used?

Pramoxine comes as a gel or spray to apply to the skin. Pramoxine also comes as a cream, foam, lotion, or solution (liquid) to apply to the rectal area. The solution comes as individual pledgets (medicated wipes for one time use). Pramoxine is usually applied to the affected area several times a day. Pramoxine cream or pledgets may be used up to five times a day;the spray or gel may be used 3 or 4 times daily. Pramoxine hemorrhoidal cream, lotion, and foam may be applied after bowel movements as needed or directed. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use pramoxine exactly as directed. Do not use more or less of it or use it more often or for a longer time than described on the package or prescribed by your doctor.

If your symptoms continue for longer than seven days, your condition worsens, or your condition clears up for a few days and then comes back, stop using pramoxine and call your doctor.

Be careful not to get pramoxine into your eyes or nose. If pramoxine gets into your eyes, flush them with water and call your doctor.

You should not apply pramoxine to open wounds, areas of skin that are damaged or blistered, deep wounds,or large areas. Unless directed by your doctor, do not use bandages or wraps after pramoxine is applied.

Do not put moistened medication pads, cream, gel, or foam into your rectum with your fingers or any device.

To use pramoxine cream, gel, or spray, or lotion, follow these steps:

Wash your hands.
Clean the affected area with mild soap and warm water. Rinse thoroughly.
Pat affected area dry with a clean, soft cloth or tissue.
Apply small amount of pramoxine to affected area.
Wash hands thoroughly.

To use pramoxine pledgets, follow these steps:

Wash your hands.
Clean affected rectal area with mild soap and warm water. Rinse thoroughly.
Gently dry by patting or blotting with a clean, soft cloth or tissue.
Open sealed pouch and remove pledget.
Apply medication from pledget to affected rectal area by patting. If needed, fold pledget and leave in place for up to 15 minutes.
Remove pledget, and dispose of it, out of reach of children.
Wash your hands thoroughly.

To use pramoxine hemorrhoidal foam, follow these steps:

Wash your hands.
Clean affected area with mild soap and warm water. Rinse thoroughly.
Gently dry by patting or blotting with a clean, soft cloth or tissue.
Shake the foam container.
Squirt a small amount of foam onto a clean tissue and apply to affected rectal area.
Wash your hands thoroughly.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using pramoxine,

tell your doctor and pharmacist if you are allergic to pramoxine, other topical anesthetics, or any other medication.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are using.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pramoxine, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep pramoxine aerosol container, spray or lotion away from fire, flame, or extreme heat. Do not throw pramoxine aerosol containers away in an incinerator.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist or doctor any questions you have about pramoxine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2017.