Thera-Gesic (Topical application)

Menthol and methyl salicylate combination topical is used to relieve minor pain from arthritis, simple backache, bruises, cramps, muscle strains, or sprains. This medicine is a topical analgesic.

This medicine is available without a prescription.

If your or your child's symptoms do not improve for more than 7 days, or if they get worse, contact your doctor.

Contact your doctor immediately if you or your child experience a skin rash, burning, stinging, swelling, or skin irritation.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been performed on the effects of menthol and methyl salicylate topical in children younger than 12 years of age. Safety and effectiveness have not been established.

Geriatric

No information is available on the effects of menthol and methyl salicylate topical 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. In these situations, your doctor may want to adjust the dose, or other precautions might be necessary. When taking this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below have been chosen based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to aspirin or salicylates—Use with caution. May worsen this condition.

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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Blistering, burning, itching, pain, redness, or swelling of the skin where the medicine is applied

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

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

In the U.S.

• Benalg
• Thera-Gesic

In Canada

• Analgesic Balm
• Bengay Original
• Buckley's Pain Relief Rub

Chemical Class: Salicylate, Non-Aspirin

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not apply to wounds, or broken, damaged, or irritated skin. Rinse it off right away if it does get on these areas.

Follow the instructions on the medicine label if you are using this medicine without a prescription.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage tightly, or apply heat (eg, heating pads) or a medicated patch to the treated skin area. Do not expose the treated skin area to direct sunlight.

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 forms (balm, cream, and stick):For relief of minor pains: Adults and children 12 years of age and older—Apply to the affected area of the skin not more than 4 times a day. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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.