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Formulation : Gel
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Indications

Orajel Extra Strength, which contains 20% w/w Benzocaine, is primarily indicated for temporary relief of toothache pain associated with a broken tooth or a tooth that may require a filling.

Benzocaine, the active ingredient in Orajel Extra Strength, is used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.

Use and Dosage

Follow all directions on the product package. If your doctor has prescribed this medication, use it as directed. If you have any questions, ask your doctor or pharmacist.

Do not use this medication more than 4 times a day unless directed by your doctor. Allow the medication to stay on the painful area for at least 1 minute before spitting out or rinsing the mouth.

Do not use large amounts of this drug or use it more often than directed because the risk for serious side effects (including rarely fatal methemoglobinemia) will increase.

Avoid getting this medication in the eyes.

Stop using this medication and tell your doctor if your sore throat is severe if it lasts for more than 2 days, or if your sore mouth symptoms last more than 7 days, or if you have a fever, headache, rash, swelling, nausea, or vomiting. You may have a serious medical problem that may require different treatment. If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.

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:

  • 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: hives; difficulty breathing; 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
  • 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
  • Dry white flakes where the medicine was applied

This is not a complete list of side effects and others may occur.

Cautions

  • Before using benzocaine, tell your doctor or pharmacist if you are allergic to it; or to other “caine” anesthetics (such as procaine) 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.
  • If you have any of the following health problems, consult your doctor or pharmacist before using this product: heart disease, certain blood disorders (G6PD deficiency, pyruvate kinase deficiency, hemoglobin-M disease, NADH-methemoglobin reductase deficiency), breathing problems (such as asthma, bronchitis, emphysema, smoking 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 product should be used only when needed. Discuss the risks and benefits with your doctor.
  • It is unknown if this product passes into breast milk. Consult your doctor before breast-feeding.

Forms and Strengths

Orajel Extra Strength is available in the following forms and strengths:

  • Orajel Extra Strength Gel:
    • 20%

FAQ

What happens if I miss a dose?

Since Orajel is used when needed, you may not be on a dosing schedule. Skip any missed dose if it is almost time for your next dose.

What happens if I overdose?

Seek emergency medical attention. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while using Orajel?

Avoid eating within 1 hour after using Orajel on your gums or inside your mouth.

Avoid getting Orajel in your eyes. Avoid swallowing the gel while applying it to your gums or the inside of your mouth.

Resources:

  1. https://www.webmd.com/drugs/2/drug-10512/orajel-maximum-strength-mucous-membrane/details
  2. https://www.drugs.com/orajel.html#side-effects
  3. https://www.everydayhealth.com/drugs/orajel

Additional information

Formulation:

Gel