Orabase-B (Oral, Oromucosal)

Benzocaine helps relieve pain and irritation from a sore throat, sore mouth, or canker sores.

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

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

After putting this medicine on 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 enters the mouth or is swallowed.

This medicine may cause a rare but serious blood issue called methemoglobinemia. This condition can 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, older adults, or those with certain genetic conditions. It is more likely to happen if too much medicine is used, but it can also occur 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-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

Contact your doctor immediately if you have a severe sore throat or sore throat accompanied by a high fever, headache, nausea, or vomiting. These may 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 consider the risks and benefits. Here are some important things to think about for this medicine:

Allergies

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

Pediatric

Because benzocaine can be toxic, it is not recommended for use in children under 2 years of age.

There is no information available about the effects of Cepacol® lozenges in children. Safety and effectiveness have not been established for children younger than 5 years.

Geriatric

There is no information available about the effects of benzocaine in older adults. However, elderly patients may be more likely to experience blood problems (e.g., methemoglobinemia), which may require caution when using benzocaine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and 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 very important for your healthcare professional to know if you are taking any of the following medicines, as interactions may occur. The following interactions are significant but not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Hyaluronidase
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

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

• Infection in or around your mouth or
• Large sores in or around your mouth—The chance of side effects may be increased.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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

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 occur in some patients. If you notice any other effects, talk to your healthcare professional.

Call your doctor for medical advice about side effects. You can 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.