Calmoseptine

Menthol and zinc oxide topical ointment is used to prevent 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.

This product is available in the following dosage forms:

• Paste
• Ointment
• Powder

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pediatric Population:
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of menthol and zinc oxide topical ointment in children.

3. Geriatric Population:
No information is available on the relationship of age to the effects of menthol and zinc oxide topical ointment in geriatric patients.

4. Drug Interactions:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

5. Other Interactions:
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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.

If your or your child's symptoms do not improve within 7 days, or if they become worse, check with your doctor.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:
Incidence not known

• Hives, Itching, or Skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.