Side Effects

Redness, warmth, or irritation at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop using this medication and tell your doctor right away if you have any serious side effects, including: blistering/swelling at the application site, increased/unusual pain at the application site.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Uses

Different brands of this product have different uses. Some brands are used to treat minor aches and pains of the muscles/joints (such as arthritis, backache, sprains). Some brands are used to help relieve itching and skin irritation (such as due to sunburn, insect bites, or minor scrapes). Menthol is known as a counterirritant. It works by causing the skin to feel cool and then warm.

How to use X-Treme Freeze 4 % Topical Gel

If you are using the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed.

This medication is for use on the skin only. Apply to the affected area no more than 3 to 4 times a day. If you are using the cream, gel, or liquid, rub in gently and thoroughly. Some liquid forms of this medication should be shaken before use. Check the manufacturer’s information for specific directions. Let the medicine dry completely before letting anyone else touch the area.

Wash your hands well after applying unless you are using this medication to treat the hands. Avoid getting this medication in your eyes, nose, or mouth. If you do get the medication in those areas, flush with plenty of water.

Do not apply to serious burns or deep wounds. Do not bandage or tightly wrap the affected area. Doing so may increase the risk of side effects. You may cover the area loosely to protect clothing.

Heat can increase the risk of side effects. Do not apply this medication right before, during, or after activities that increase skin temperature (such as bathing, swimming, heavy exercise). Wait until your skin has cooled before applying the medication. Do not use a sunlamp/tanning bed, hot water bottle, or heating pad/device on the treated area.

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Read the label carefully to make sure you have the right product for you. Ask your pharmacist if you have any questions.

Tell your doctor if your condition lasts for more than 7 days, or if it gets worse, or if it keeps returning. If you think you may have a serious medical problem, get medical help right away.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to menthol; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Keep all regular medical and lab appointments.

If you are using this product on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.