Dent-O-Kain/20 (Oral, Oromucosal)

Benzocaine is used to ease pain and irritation from a sore throat, sore mouth, or canker sores.

You can get this medicine without a prescription. Your doctor may have specific instructions on how to use it and the right dose for your medical issue.

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

After applying this medicine to your child's skin, watch them closely to ensure they do 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 swallowed or gets into the mouth.

This medicine may cause a rare but serious blood issue called methemoglobinemia. This condition may 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 children younger than 2 years, elderly patients, or those with certain genetic conditions. It is more likely to occur if too much of the medicine is used, but it can also happen with small amounts. Keep this medicine out of reach of children. Call your doctor immediately if you or your child experiences any of the following symptoms after using this medicine: pale, gray, or blue skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

Contact your doctor right away if you develop a severe sore throat or a sore throat along with a high fever, headache, nausea, or vomiting. These could be signs of an infection.

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, you and your doctor need to weigh the risks against the benefits. Here are some important considerations for this medicine:

Allergies

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

Pediatric

Because benzocaine can be harmful, it is not recommended for use in children under 2 years of age. There is no information on how age affects the use of Cepacol® lozenges in children. Safety and effectiveness have not been established for children younger than 5 years old.

Geriatric

There is no information on how age affects the use of benzocaine in older patients. However, older adults are more likely to have blood problems (like methemoglobinemia), which may require caution when using benzocaine.

Breast Feeding

There are no adequate studies to determine if using this medication during breastfeeding poses a risk to infants. You should weigh 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 others may be used together with caution. If you are taking this medicine, it is important for your healthcare professional to know if you are also taking any of the following medicines. The following interactions are significant but may not include all possible interactions.

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

• Hyaluronidase
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Heart disease
• Hereditary metabolic disorders affecting red blood cells (such as G6PD deficiency, hemoglobin-M disease, NADH-methemoglobin reductase deficiency, pyruvate-kinase deficiency)
• Lung or breathing issues (such as asthma, bronchitis, emphysema)—Use with caution. This may increase the risk of a serious side effect called methemoglobinemia.

• Infection in or around your mouth
• Large sores in or around your mouth—This may increase the chance of side effects.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you may need medical attention.

Check with your doctor right away if any of the following side effects happen:

Incidence not known

• Bluish-colored lips, fingernails, or palms
• dark urine
• difficulty breathing
• dizziness or lightheadedness
• headache
• high fever
• nausea
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• worsening of pain, redness, swelling, or irritation in or around the mouth

Other side effects not listed may also happen in some patients. If you notice any other effects, talk to 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.

• Anbesol
• Babee Teething
• Benzodent
• Benz-O-Sthetic
• Bi-Zets/Benzo-Troches
• Dentemp's
• Dent-O-Kain/20
• Detane
• Gumsol
• HAD
• Hurricaine
• Hurricane Spray Kit
• Kank-A Soft Brush
• Larynex
• Miradyne-3
• Mycinette
• Orabase-B
• Oracaine
• Ora film
• Orajel
• OraMagic Plus
• Orasol
• Red Cross Canker Sore
• Thorets
• Trocaine
• Zetts
• Zilactin
• Zilactin-B

In Canada

• Anbesol Extra Strength
• Anbesol Liquid
• Baby Anbesol
• Baby Orajel
• Baby Orajel Liquid
• Maximum Strength Orajel Pm
• Orajel Extra Strength

Available Dosage Forms:

• Gel/Jelly
• Paste
• Lotion
• Spray
• Powder for Suspension
• Cream
• Swab
• Solution
• Lozenge/Troche
• Ointment

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.

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.

Do not use this medicine for more than 2 days without checking first with your doctor.

In children, instead of using this medicine, talk with your child's doctor about different ways to treat teething. Give your child a firm rubber 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 sore throat and mouth pain: For oral dosage form (lozenges): Adults and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed. Children younger than 5 years of age—Use is not recommended. For oral dosage form (gel, spray, ointment, or solution): Adults and children 2 years of age and older—Apply to the affected area as needed. However, do not use it for more than 4 times a day. Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.