Orajel

Dosage form: Topical gel, topical cream, topical swabs, topical liquid
Drug class: Topical anesthetics

Usage of Orajel

Orajel is a topical treatment for the mouth and gums that may be used to relieve pain associated with minor mouth problems. Orajel is available as a medicated or nonmedicated formulation.

Medicated formulations of Orajel contain benzocaine and are intended for use by adults and children over the age of 12. They can be used by children aged 2 to 12 years if under the guidance of a doctor and an adult supervising how much they use. Because benzocaine numbs the skin or surfaces inside the mouth it can be effective at temporarily relieving pain caused by a sore throat, canker sores, cold sores, fever blisters, minor irritation, or injury of the mouth and gums.

Nonmedicated formulations of Orajel (such as Orajel Baby) do not contain benzocaine. They are also free of artificial colors and sweeteners, menthol, parabens, Belladonna, sodium lauryl sulfate (SLS), gluten, dairy, and eugenol (clove oil). These products are marketed for use during teething; however, the American Academy of Pediatrics (AAP) discourages their use because they wash out of the baby’s mouth within minutes and may present safety concerns. Instead, the AAP suggests using a teething ring made of firm rubber (not frozen) or gently rubbing or massaging the child’s gums with a finger to relieve symptoms.

Benzocaine is a local anesthetic (numbing medication) that works by blocking nerve signals in your body. The use of topical benzocaine has been associated with methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a), which is a potentially life-threatening condition that affects how red blood cells deliver oxygen around your body. This is why topical medicated Orajel products now display a warning about methemoglobinemia and why the FDA has said these products should not be used by children under the age of 2.

Signs and symptoms of methemoglobinemia may include pale, gray- or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; headache; lightheadedness; or a rapid heart rate. Symptoms may occur the first time you use benzocaine or after many uses, and may appear within minutes to 1 to 2 hours. If any symptoms occur, the person should receive medical attention immediately.

Orajel side effects

Orajel used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Orajel in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

a headache, tiredness, confusion

fast heartbeats

feeling light-headed or short of breath

pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction to Orajel, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

severe burning, stinging, or sensitivity where the medicine is applied

swelling, warmth, or redness or

oozing, blistering, or any signs of infection.

Common Orajel side effects may include:

mild stinging, burning, or itching where the medicine is applied

skin tenderness or redness or

dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Orajel

Do not use medicated Orajel if you have ever had methemoglobinemia in the past.

Ask a doctor or pharmacist if Orajel is safe to use if you:

have a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency disorder

have asthma, bronchitis, emphysema, or other breathing disorder

have heart disease

smoke

are pregnant or breast-feeding.

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How to use Orajel

Use Orajel exactly as directed on the label, or as prescribed by your doctor. Read all medication guides or instruction sheets. Do not use more than is recommended. Use the smallest amount needed to numb the skin or relieve pain. Your body may absorb more benzocaine if you use too much, or if you apply it over large areas.

Seek emergency help if you develop symptoms of methemoglobinemia. Call your doctor if your mouth symptoms do not improve or if they get worse within the first 7 days of using Orajel. Also, call your doctor if your symptoms have cleared up but then come back.

Warnings

Use of medicated Orajel products containing benzocaine has been associated with potentially fatal methemoglobinemia. Do not use this medicine if you have ever had methemoglobinemia. Do not use benzocaine-containing topical products in children under the age of 2.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA, such as a headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

An overdose of benzocaine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This can happen if you apply more than the recommended dose. Use the smallest amount needed, even in adults and older children.

Do not use medicated Orajel products that contain benzocaine if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.

Do not use medicated Orajel products on a child younger than 2 years old.

What other drugs will affect Orajel

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.