Chiggerex (Topical application)

Benzocaine is used to ease 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 numbs 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 dose for your medical condition.

If your or your child's condition does not improve within 7 days, or if it becomes worse, check with your doctor.

After applying this medicine to your child's skin, watch them closely to ensure they do not get any of the medicine into their eyes or mouth. It can cause serious side effects, especially in children, if any of the medicine gets into the mouth or is swallowed.

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

Do not use cosmetics or other skin care products on the treated skin areas.

This medicine may cause a rare but serious blood problem called methemoglobinemia. This condition may occur after using the spray for medical procedures or after 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 of age, elderly patients, or patients with certain genetic conditions. It has happened when patients receive too much of the medicine, but can also occur with small amounts. Make sure you store this medicine out of reach of children. Call your doctor right away if you or your child experience 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 knows 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, it's important to consider the risks compared to the benefits it will provide. This decision should be made between you and your doctor. For this medicine, the following factors should be taken into account:

Allergies

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

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 regarding 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. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In such cases, your doctor might adjust the dose, or other precautions may be necessary. It is very important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions have been selected based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Hyaluronidase
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around meal times or with certain types of food due to possible interactions. Combining alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine is used. Make sure to tell your doctor if you have any other medical conditions, 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. This 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. This 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. Not all of these side effects will occur, but if they do, 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.