Mandelay (Topical application)

Benzocaine is used to help relieve pain and itching from conditions like sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Benzocaine is part of a group of medicines called topical local anesthetics. It works by numbing the nerve endings in the skin. This medicine does not make you unconscious like general anesthetics do when used for surgery.

This medicine is available without a prescription; however, your doctor may have specific instructions on how to use it and the right dose for your medical condition.

If your or your child's condition does not improve within 7 days, or if it worsens, contact your doctor.

After you apply this medicine to your child's skin, closely monitor the child to ensure that he or she does not get any of the medicine in their eyes or mouth. It can cause serious side effects, especially in children, if any of the medicine is ingested.

Stop using this medicine and contact your doctor immediately if you or your child experience a skin rash, burning, stinging, swelling, or irritation of the skin.

Do not apply cosmetics or other skin care products to the treated skin areas.

This medicine may cause a rare but serious blood condition called methemoglobinemia. This can happen after using the spray for medical procedures or using the over-the-counter gel or liquid for mouth sores or teething in children. The risk may be higher in infants younger than 4 months, elderly patients, or patients with certain genetic conditions. It has happened when patients received too much of the medicine, but it can also occur with small amounts. Keep this medicine out of reach of children. Contact your doctor immediately if you or your child show any of the following symptoms after using this medicine: pale, gray, or blue-colored skin, lips, or nails; confusion; headache; lightheadedness; fast heartbeat; shortness of breath; or unusual tiredness or weakness.

Make sure your doctor is aware if you are also taking medicines that contain nitrates or nitrites. This includes nitroglycerin, Imdur®, Isordil®, Nitro-Bid®, Nitrostat®, or Transderm-Nitro®.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make. 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 healthcare 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.

Pediatric

Due to benzocaine's toxicity, it is not recommended for use in children under 2 years of age.

Geriatric

There is no information available on how age affects the effects of benzocaine in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

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 may be needed. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance 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 frequency of use for one or both medicines.

• Hyaluronidase
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Anemia or
• Glucose-6-phosphodiesterase deficiency (a hereditary metabolic disorder affecting red blood cells) or
• Hemoglobin-M disease (a hereditary metabolic disorder affecting red blood cells) or
• NADH-methemoglobin reductase deficiency (a hereditary metabolic disorder affecting red blood cells) or
• Pyruvate-kinase deficiency (a hereditary metabolic disorder affecting red blood cells)—Use with caution. May increase the risk of a serious side effect called methemoglobinemia.

• Asthma or
• Bronchitis or
• Emphysema or
• Heart disease or
• Infection at the application site or
• Large sore, broken skin, or injury at the application site or
• Smokers—Use with caution. May worsen side effects.

• Children under the age of 2 years—Should not be used in this age group.

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

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

Rare

• Bluish color of the fingernails, lips, skin, palms, or nail beds

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• Cracking, itching, redness, or stinging of the skin
• Dark urine
• Difficulty with breathing
• Difficulty with walking
• Dizziness or lightheadedness
• Fainting
• Fever
• Headache
• Inability to feel hands and feet
• Irritability
• Irritation of the nose
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Pale skin
• Rapid heart rate
• Red, sore eyes
• Shortness of breath
• Sore throat
• Unusual bleeding or bruising
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Unusual tiredness or weakness

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.

In the U.S.

• Anacaine
• Chiggerex
• Mandelay
• Medicone
• Outgro
• Solarcaine

In Canada

• Baby Orajel Nighttime Formula
• Dermoplast Maximum Strength
• Topicaine

Available Dosage Forms:

• Solution
• Gel/Jelly
• Spray
• Liquid
• Cream
• Ointment

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Use this medicine exactly as directed by your doctor. Do not use it for any other reason without first checking with your doctor. This medicine may be more likely than other topical anesthetics to cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Be careful not to get any of this medicine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get into these areas especially the eyes, wash it with water for at least 15 minutes and check with your doctor right away.

If you are using a spray form of this medicine, do not spray it directly on your face. Instead, use your hand or an applicator (e.g., a sterile gauze pad or a cotton swab) to apply the medicine.

To use the pad or swab, open the package according to the directions. When treating a bee sting, remove the stinger before using the medicine. Wipe the pad or swab across the affected skin area.

Read the package label very carefully to see if the product contains any alcohol. Alcohol is flammable and can catch on fire. Do not use any product containing alcohol near a fire or open flame, or while smoking. Also, do not smoke after applying one of these products until it has completely dried.

If you are using the gel or liquid form:

• Use the benzocaine gel or liquid only when needed, but not for more than four times a day.
• In children, instead of using this medicine, talk with your pediatrician about different ways to treat teething. Give your child a chilled teething ring, or gently rub or massage your child's gums with your finger to relieve symptoms of teething pain. Do not use this medicine in children under the age of 2 unless your doctor tells you to.

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 (aerosol spray, pads, or swabs): For pain and itching caused by minor skin conditions: Adults, teenagers, and children 2 years of age and older—Apply to the affected area three or four times a day as needed. Children younger than 2 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.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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.