Calmoseptine (Topical application)

Menthol and zinc oxide topical ointment is used to stop and heal skin irritation caused by urine, diarrhea, sweat, fistula damage, feeding tube site leakage, wound drainage, minor burns, cuts, scrapes, or itching.

This medicine is available as an over-the-counter (OTC) product.

If your symptoms or your child's symptoms do not get better within 7 days, or if they get worse, contact your doctor.

If you or your child accidentally swallow the medicine, call the doctor or a poison control center immediately.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it versus the benefits it will provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research done so far has not shown any specific problems that would limit the use of menthol and zinc oxide topical ointment in children.

Geriatric

There is no information available about how age affects the results of menthol and zinc oxide topical ointment in older patients.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If this is the case, your doctor may want to adjust the dose, or other precautions may be needed. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Hives, itching, or skin rash

Other side effects not listed may also happen in some patients. If you notice any other effects, talk to your healthcare professional.

Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Calmoseptine
• Gold Bond Medicated Body Powder
• Gold Star Medicated
• Risamine

Available Dosage Forms:

• Paste
• Ointment
• Powder

Therapeutic Class: Protectant, Dermatological

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

This medicine is for use on the skin only. Do not get it in the eyes. Do not use on deep or puncture wounds. You may use it on the skin area around the wound.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Clean the affected area with mild soap and water. Pat dry or allow it to dry.
• Apply a thin layer of the ointment with each diaper change, at bedtime, or when prolonged exposure to wet diapers may occur.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (ointment):For prevention of skin irritation: Adults—Apply to the affected area of the skin 2 to 4 times per day. Children—Apply to the affected area of the skin 2 to 4 times per day.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.