RectaSmooth (rectal)

RectaSmooth (for the rectum) is a local anesthetic (numbing medication).

RectaSmooth is a local anesthetic (numbing medication) used to help adults and children who are at least 12 years old feel temporary relief from pain, itching, and burning caused by hemorrhoids or other issues in the rectum and anus.

RectaSmooth may also be used for reasons not mentioned in this medication guide.

Follow all directions on the label and package.

Use exactly as directed.

Tell your healthcare provider if you use other medicines or have other medical conditions or allergies.

You should not use RectaSmooth if you are allergic to it.

Fatal overdoses have happened when numbing medicines were used without the guidance of a medical doctor (for example, during cosmetic procedures like laser hair removal). Be aware that many cosmetic procedures are done without a medical doctor present.

Ask a doctor or pharmacist before using RectaSmooth if you have health issues, use other medications, or if you are pregnant or breastfeeding.

Do not give this medicine to a child younger than 12 years old without medical advice.

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

RectaSmooth may cause serious side effects. Stop using RectaSmooth and call your doctor immediately if you experience:

• rectal bleeding; or
• redness, irritation, swelling, or pain that develop or increase.

Less serious side effects may happen more often, or you may not experience any 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 can report side effects to the FDA at 1-800-FDA-1088.

Use exactly as directed on the label, or as prescribed by your doctor.

RectaSmooth is for use only around the outside of your anus. Do not apply this medicine directly in the rectum using your fingers, any mechanical device, or applicator.

RectaSmooth is usually applied 1 to 6 times daily. Do not use this medicine more often or longer than directed.

Wash your hands before and after applying this medicine.

When possible, clean the affected area with warm water and mild soap, and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before using RectaSmooth.

Use only a small amount of medicine on the affected area. Do not apply this medicine to skin that is raw or blistered, such as a severe burn or abrasion.

Stop using this medicine and call your doctor if your symptoms do not improve after 7 days, if it gets worse, or if it clears up and then comes back in a few days.

RectaSmooth gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Store at room temperature away from moisture and heat. Do not freeze.

RectaSmooth (rectal) is used as needed. If you miss a dose while on a dosing schedule, skip it. Do not use two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Do not get RectaSmooth in your eyes. If contact does occur, rinse with water.

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

Other drugs may affect RectaSmooth, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.