Uses

What is Calmoseptine used for?

Calmoseptine is commonly used to treat and prevent minor skin irritations like those resulting from diarrhea, burns, cuts, and scrapes.

Calmoseptine may also be used for other conditions as determined by your healthcare provider.

How does Calmoseptine work (mechanism of action)?

Calmoseptine protects the skin and helps it heal by forming a barrier against irritation and moisture.

How is Calmoseptine supplied (dosage forms)?

Calmoseptine is available in the following dosage form that is applied to the skin.

  • 0.44%menthol/20.6% zinc oxide topical ointment

How should I store Calmoseptine?

Calmoseptine should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Calmoseptine?

The most common side effects of Calmoseptine are skin redness, warmth, or irritation. Tell your healthcare provider if you have any of these side effects that bother you.

There may be other side effects of Calmoseptine that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Calmoseptine?

While less common, the most serious side effects of Calmoseptine are described below, along with what to do if they happen.

Severe Allergic Reactions. Calmoseptine can cause allergic reactions, which can be serious. Stop using Calmoseptine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble in swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or feeling like you are about to pass out
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Calmoseptine?

Allergies to Ingredients. People who are allergic to any of the following should not use Calmoseptine.

  • Calmoseptine
  • Menthol
  • Zinc oxide
  • Any of the ingredients in the specific product

Your pharmacist can tell you all of the ingredients in Calmoseptine.

What should I know about Calmoseptine before using it?

Keep Calmoseptine out of the reach of children.

Calmoseptine is only for use on the skin. It is not for deep or puncture wounds.

Avoid touching your eyes while applying Calmoseptine on the affected skin.

Before applying Calmoseptine, the skin should be gently cleansed with a mild skin cleanser and patted dry.

What should I tell my healthcare provider before using Calmoseptine?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Calmoseptine is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Calmoseptine while you are pregnant or trying to get pregnant.

Breastfeeding. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Calmoseptine while breastfeeding.

How can I get more information about Calmoseptine?

For more information about Calmoseptine, you can visit the manufacturer’s website at www.calmoseptine.com or call them at 800-800-3405.

Interactions

Does Calmoseptine interact with foods or drinks?

There are no known interactions between Calmoseptine and foods or drinks.

There are no known interactions between Calmoseptine and alcohol.

Does Calmoseptine interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does Calmoseptine 0.44 %-20.6 % Topical Ointment Dermatological Irritants-Counter-Irritant Formulations interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Calmoseptine?

If you or someone else has used too much Calmoseptine, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Calmoseptine?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.

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