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|Zilactin-L Dental

ANESTHETICS (Dental)

Some commonly used brand names are:

In the U.S.—

• Anbesol, Baby ¹
• Anbesol Maximum Strength Gel ¹
• Anbesol Maximum Strength Liquid ¹
• Anbesol Regular Strength Gel ³
• Anbesol Regular Strength Liquid ³
• Benzodent ¹
• Chloraseptic Lozenges ²
• Chloraseptic Lozenges, Children"s ¹
• Dentapaine ¹
• Dent-Zel-Ite ¹
• Hurricaine ¹
• Numzident ¹
• Num-Zit Gel ¹
• Num-Zit Lotion ¹
• Orabase, Baby ¹
• Orabase-B with Benzocaine ¹
• Orajel, Baby ¹
• Orajel Maximum Strength ¹
• Orajel Nighttime Formula, Baby ¹
• Oratect Gel ¹
• Rid-A-Pain ¹
• SensoGARD Canker Sore Relief ¹
• Spec-T Sore Throat Anesthetic ¹
• Sucrets, Children"s ⁴
• Sucrets Maximum Strength ⁴
• Sucrets Regular Strength ⁴
• Xylocaine ⁵
• Xylocaine Viscous ⁵
• Zilactin-L ⁵

In Canada—

• Anbesol Baby Jel ¹
• Anbesol Gel ³
• Anbesol Liquid ³
• Anbesol Maximum Strength Liquid ³
• Chloraseptic Lozenges Cherry Flavor ²
• Dentocaine ¹
• Orajel, Baby ¹
• Orajel Extra Strength ¹
• Orajel Liquid ¹
• Topicaine ¹
• Xylocaine ⁵
• Xylocaine Viscous ⁵

Other commonly used names are: dyclocaine ethyl aminobenzoate lignocaine

Category

• Anesthetic (mucosal-local)—Benzocaine; Benzocaine and Menthol; Benzocaine and Phenol; Dyclonine; Lidocaine

Description

Dental anesthetics (an-ess-THET-iks) are used in the mouth to relieve pain or irritation caused by many conditions. Examples include toothache, teething, and sores in or around the mouth, such as cold sores, canker sores, and fever blisters. Also, some of these medicines are used to relieve pain or irritation caused by dentures or other dental appliances, including braces. However, if you have an infection or a lot of large sores in your mouth, check with your medical doctor or dentist before using a dental anesthetic because other kinds of treatment may be needed. Also, the chance of side effects is increased.

One form of lidocaine is also used to relieve pain caused by certain throat conditions. Some forms of benzocaine, benzocaine and menthol combination, and dyclonine are also used to relieve sore throat pain.

Some of these medicines are available only with your medical doctor"s or dentist"s prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper use and dose for your medical problem. Some nonprescription (over-the-counter [OTC]) aerosols, gels, liquids, or ointments that contain a local anesthetic are not meant to be used in or around the mouth. If you have any questions about which product to use, check with your pharmacist.

These medicines are available in the following dosage forms:

• Dental
• Benzocaine
  • Aerosol spray (U.S.)
  • Dental paste (U.S.)
  • Film-forming gel (U.S.)
  • Gel (U.S. and Canada)
  • Lozenges (U.S.)
  • Ointment (U.S. and Canada)
  • Solution (liquid) (U.S. and Canada)
• Benzocaine and Menthol
  • Lozenges (U.S. and Canada)
• Benzocaine and Phenol
  • Gel (U.S. and Canada)
  • Solution (liquid) (U.S. and Canada)
• Dyclonine
  • Lozenges (U.S.)
• Lidocaine
  • Aerosol spray (U.S. and Canada)
  • Ointment (U.S. and Canada)
  • Solution (U.S. and Canada)
  • Viscous (very thick) solution (U.S. and Canada)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For dental anesthetics, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to a local anesthetic, especially one that was applied to any part of the body as a liquid, cream, ointment, or spray. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Dental anesthetics have not been reported to cause birth defects or other problems in humans.

Breast-feeding—Dental anesthetics have not been reported to cause problems in nursing babies.

Children—Children may be especially sensitive to the effects of dental anesthetics. This may increase the chance of unwanted effects, some of which can be serious, during treatment. When using a dental anesthetic for a child, be very careful not to use more of the medicine than directed on the label, unless otherwise directed by your health care professional. Teething medicines that contain benzocaine may be used in babies 4 months of age and older. One product that contains benzocaine (Orabase-B with Benzocaine) may be used in children 6 years of age and older. Most of the other nonprescription (over-the-counter [OTC]) medicines that contain a dental anesthetic may be used in children 2 years of age and older. However, these other nonprescription products should not be used in infants or children younger than 2 years of age unless prescribed by a health care professional.

Older adults—Elderly people are especially sensitive to the effects of many local anesthetics. This may increase the chance of side effects during treatment, especially with lidocaine. Nonprescription (over-the-counter [OTC]) products containing local anesthetics are not likely to cause problems. However, elderly people should be especially careful not to use more medicine than directed on the package label, unless otherwise directed by a medical doctor or a dentist.

Other medicines—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. Before you use a dental anesthetic, check with your medical doctor, dentist, or pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Proper Use of This Medicine

For safe and effective use of this medicine:

• Follow your medical doctor"s or dentist"s instructions if this medicine was prescribed.
• Follow the manufacturer"s package directions if you are treating yourself.
• Do not use more of this medicine, 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 is particularly important for young children and elderly patients, especially with lidocaine.
• Dental anesthetics should be used only for conditions being treated by your medical doctor or dentist or for problems listed in the package directions. Do not use any of them for other problems without first checking with your medical doctor or dentist . These medicines should not be used if certain kinds of infections are present.

To use the viscous (very thick) liquid form of lidocaine (e.g., Xylocaine Viscous):

• This medicine may cause serious side effects if too much of it is swallowed. Be certain that you understand exactly how you are to use this medicine, and whether or not you are to swallow it. Follow your medical doctor"s or dentist"s directions very carefully. Also, be very careful to measure the exact amount of medicine that you are to use . Use a special measuring spoon to measure the amount; regular household teaspoons or soup spoons that you use at the table may not measure the amount correctly. These measures are especially important when this medicine is used for young children, who are especially sensitive to its effects.
• If you are using this medicine for a problem in the mouth, you may apply it to the sore places with a cotton-tipped applicator. Or, you may swish the measured amount of medicine around in your mouth until you are certain that it has reached all of the sore places. Do not swallow the medicine unless your medical doctor or dentist has told you to do so .
• If you are using this medicine for a problem in the throat, gargle with the measured amount of medicine as directed by your doctor. Do not swallow the medicine unless your doctor has told you to do so .

To use benzocaine film-forming gel (e.g., Oratect Gel):

• Children may find it difficult to apply this medicine correctly. They should be helped by an adult.
• First, dry the area where the medicine is needed, using a swab included in the package.
• Apply the gel to a second swab. Then roll the swab over the dried area.
• Keep your mouth open and dry for about 30 to 60 seconds after applying the medicine. A film will form where you placed the medicine.
• Do not remove the film. It will slowly disappear and should be gone about 6 hours after the medicine was applied.

To use other gel or liquid forms of a dental anesthetic :

• Apply the medicine to the sore places with a clean finger, a cotton-tipped applicator, or a piece of gauze.
• When relieving pain caused by dentures or other dental appliances, do not apply this medicine directly to the appliance, and do not place the appliance in your mouth while the medicine is there , unless directed to do so by your dentist. Instead, apply the medicine to the sore areas in your mouth and wait until the pain is relieved. Then rinse your mouth with water before replacing the appliance.

To use benzocaine dental paste (e.g., Orabase-B with Benzocaine):

• Use a cotton-tipped applicator to dab small amounts of the medicine onto the sore places. Do not rub or try to spread the medicine with your finger while you are applying it, because the medicine will become crumbly and gritty.

To use aerosol or spray forms of a dental anesthetic :

• To help prevent unwanted effects, be very careful not to inhale (breathe in) the medicine. Also, do not spray the back of your mouth or throat with it unless your medical doctor or dentist directs you to do so.

To use lozenge forms of benzocaine, benzocaine and menthol, or dyclonine :

• These lozenges should be dissolved slowly in the mouth. Do not bite or chew them or swallow them whole. Before giving a lozenge to a young child, be sure that the child understands these directions and will follow them.

Dosing—The dose of these medicines will be different for different patients. Follow your health care professional"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your medical doctor or dentist tells you to do so.

• For benzocaine
• For dental paste dosage form:
  • For sores in and around the mouth, sore gums, or pain caused by dental appliances:
    • Adults, teenagers, and children 6 years of age and older—Apply a small amount of the medicine to the painful areas.
    • Children up to 6 years of age—Use and dose must be determined by your health care professional.
• For film-forming gel, liquid, and ointment dosage forms:
  • For sores in and around the mouth, toothache, sore gums, or pain caused by dental appliances:
    • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.
• For gel dosage form:
  • For sores in and around the mouth, toothache, sore gums, or pain caused by dental appliances:
    • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.
  • For teething pain:
    • Infants up to 4 months of age—Use and dose must be determined by your health care professional.
    • Infants and children 4 months to 2 years of age—Apply a small amount of the 7.5% or 10% benzocaine gel to sore gums up to four times a day.
    • Children 2 years of age and older—Apply any strength of benzocaine gel to sore gums up to four times a day.
• For lozenge dosage form:
  • For pain in the mouth or throat:
    • Adults and teenagers—One lozenge, dissolved slowly in the mouth every two hours as needed.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.
    • Children 2 years of age and older—One children"s strength (5-milligram [mg]) lozenge, dissolved slowly in the mouth every two hours as needed.
• For aerosol spray dosage form:
  • For pain in the mouth:
    • Adults and teenagers—One or 2 sprays, pointed at the sore places. Each spray should last about one second.
    • Children—Use and dose must be determined by your dentist.

• For benzocaine and menthol combination
• For lozenge dosage form:
  • For pain in the mouth or throat:
    • Adults, teenagers, and children 2 years of age and older—One lozenge, dissolved slowly in the mouth every two hours as needed.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.

• For benzocaine and phenol combination
• For gel dosage form:
  • For sores in and around the mouth, teething, toothache, sore gums, or pain caused by dental appliances:
    • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.
• For liquid dosage form:
  • For sores in and around the mouth, toothache, sore gums, or pain caused by dental appliances:
    • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.

• For dyclonine
• For lozenge dosage form:
  • For pain in the mouth or throat:
    • Adults and teenagers—One 2-milligram (mg) or 3-mg lozenge, dissolved slowly in the mouth every two hours as needed.
    • Children up to 2 years of age—Use and dose must be determined by your health care professional.
    • Children 2 years of age and older—One children"s strength (1.2-mg) lozenge, dissolved slowly in the mouth every two hours as needed.

• For lidocaine
• For dental liquid dosage form (e.g., Zilactin-L):
  • For sores on the lips and around the mouth:
    • Adults and teenagers—Apply to sores every one or two hours for the first three days. Then apply as needed.
    • Children—Dose must be determined by your health care professional.
• For dental ointment dosage form:
  • For gum pain:
    • Adults—Apply a small amount of medicine to the sore places. Do not apply the ointment directly to dentures, braces, or other dental appliances, unless your dentist has directed you to do so.
    • Children—Use and dose must be determined by your health care professional.
• For aerosol spray dosage form:
  • For pain in the mouth:
    • Adults and teenagers—Two sprays, pointed at the sore places. Do not use more than twenty sprays a day.
    • Children—Use and dose must be determined by your health care professional.
• For viscous (very thick) solution dosage form (e.g., Xylocaine Viscous):
  • For pain in the mouth:
    • Adults and teenagers—One tablespoonful of medicine (or less), swished around in the mouth, then spit out. Or, apply a total of 1 tablespoonful (or less) to the sore places with a cotton-tipped applicator. This medicine should not be used more often than every three hours.
    • Infants and children up to 3 years of age—Apply a total of one-fourth of a teaspoonful (or less) to the sore places with a cotton-tipped applicator. This medicine should not be used more often than every three hours.
    • Children 3 years of age and older—Apply a small amount of medicine to the sore places with a cotton-tipped applicator. The largest amount that can be used must be determined by your health care professional.
  • For sore throat pain:
    • Adults and teenagers—One tablespoonful, used as a gargle. Swallow after gargling only if directed to do so by your doctor. Otherwise, spit out the medicine after gargling with it.
    • Children—Dose must be determined by your doctor.

Missed dose—If your health care professional has directed you to use this medicine on a regular schedule, and you miss a dose, use 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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store throat lozenge forms of benzocaine, benzocaine and menthol combination, or dyclonine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing.
• Do not puncture, break, or burn aerosol containers, even when they are empty.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your medical doctor :

• If you are using this medicine for a sore throat and your sore throat is severe or lasts for more than 2 days.
• If other symptoms, such as fever, headache, skin rash, swelling, nausea, or vomiting, are also present.

Check with your health care professional :

• If you are using this medicine for pain or sores in or around the mouth and your condition does not get better within 7 days or gets worse.
• If you notice other symptoms, such as swelling, rash, or fever.

Check with your dentist :

• If you are using this medicine for a toothache. This medicine should not be used for a long time. It is meant to relieve toothache pain temporarily, until the problem causing the toothache can be corrected. Arrange for treatment as soon as possible.
• If you are using this medicine to relieve pain caused by new dentures or other dental appliances. An adjustment to your appliance may be needed to prevent more soreness. Also, if your dentist has ordered you to apply this medicine to the appliance before inserting it or to keep the appliance in your mouth while using the medicine, he or she will want to make sure that the medicine is not causing any unwanted effects.

False test results may occur if benzocaine or lidocaine is present in your body when a certain laboratory test is done. This test uses a medicine called bentiromide (e.g., Chymex) to show how well your pancreas is working. You should not use any products containing benzocaine or lidocaine for about 72 hours (3 days) before this test is done.

If you are using this medicine in the back of the mouth, or in the throat, do not eat or drink anything for one hour after using it . When this medicine is applied to these areas, it may interfere with swallowing and cause choking.

Do not chew gum or food while your mouth or throat feels numb after you use this medicine . To do so may cause an injury. You may accidentally bite your tongue or the inside of your cheeks.

Side Effects of This Medicine

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.

Stop using this medicine and check with your medical doctor or dentist immediately if any of the following side effects occur:

Also, check with your health care professional as soon as possible if any of the following side effects occur:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your medical doctor or dentist.

Revised: 06/13/2000

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