Benzocaine (topical application route)


    Brand Name

    US Brand Name

    Anacaine

    Chiggerex

    Mandelay

    Medicone

    Outgro

    Solarcaine

    Canadian Brand Name

    Baby Orajel Nighttime Formula

    Dermoplast Maximum Strength

    Topicaine


    Description

    Benzocaine is used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

    Benzocaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness like general anesthetics do when used for surgery.

    This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical condition.

    This product is available in the following dosage forms:

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

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care 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

    Because of benzocaine's toxicity, use in children under 2 years of age is not recommended.

    Geriatric

    No information is available on the relationship of age to the effects of benzocaine in geriatric patients.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required 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.

    • Hyaluronidase
    • St John's Wort

    Other Interactions

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

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 developing a serious side effect called methemoglobinemia.
    • Asthma or
    • Bronchitis or
    • Emphysema or
    • Heart disease or
    • Infection at the place of application or
    • Large sore, broken skin, or injury at the place of application or
    • Smokers—Use with caution. May cause side effects to become worse.
    • Children under the age of 2 years—Should not be used in this age group.

    Proper Use

    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.


    Precautions

    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 the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine into his or her 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 right away if you or your child have a skin rash, burning, stinging, swelling, or irritation of your 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 use of the spray for medical procedures or use of the over-the-counter gel or liquid for mouth sores or teething in children. The risk may be increased in infants younger than 4 months of age, elderly patients, or patients with certain inborn defects. It has occurred 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 has the following symptoms after receiving 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 containing nitrates or nitrites. This includes nitroglycerin, Imdur®, Isordil®, Nitro-Bid®, Nitrostat®, or Transderm-Nitro®.


    Side Effects

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






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