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Benzocaine eent

Pronunciation

Class: Local Anesthetics
ATC Class: R02AD01
VA Class: OR900
CAS Number: 94-09-7
Brands: A/B Otic, Allergen Ear Drops, Anbesol, Anbesol Cold Sore Therapy, Auroto, Cepacol, Cetacaine, Hurricaine, Kanka-A, Orajel, Topex

Warning(s)

Special Alerts:

[Posted 04/07/2011] ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

RECOMMENDATIONS:

  • Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.

  • Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.

  • Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.

FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.

For more information visit the FDA website at: and .

Introduction

Local anesthetic.a b c d e f g h i j k l m n p r s t u

Uses for Benzocaine

Analgesia/Anesthesia of Mucous Membranes

Used for local anesthesia of oral and pharyngeal mucous membranes.a p r s

Self-medication (alone or in fixed combination with various other drugs) for the temporary relief of minor sore throat pain.a e f t u

Self-medication (alone or in fixed combination with various other drugs) for the temporary relief of mouth soreness associated with various oral conditions (e.g., cold sores, ulcerations, canker sores [aphthous stomatitis], minor injury/irritation).b c d e f i j t u

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Self-medication (alone or in fixed combination with various other drugs) for the temporary relief of pain associated with various dental conditions (e.g., toothache, sore gums, orthodontic appliances, denture irritation, teething).a b c g h k l m

Used in fixed combination with butamben and tetracaine hydrochloride to control pain as a topical anesthetic for all accessible mucous membranes except the eyes.r

Otic Pain

Used alone or in fixed combination with antipyrine for the temporary relief of ear pain (otalgia, earache) associated with otitis media of various causes; however, single ingredient preparations no longer commercially available in the US.a n

Efficacy for ear pain relief has not been established.a

Adjuvant treatment during concurrent systemic antibiotic administration for pain relief in acute otitis media.n

Topical anesthetics may provide symptomatic relief but do not preclude need for appropriate anti-infective therapy when ear pain is secondary to infection.a

Cerumen Removal

Used to facilitate the removal of excessive or impacted cerumen (earwax).n

Surgical/Procedural Local Anesthesia

Used alone or with other local anesthetic agents (e.g., fixed combination with butamben and tetracaine hydrochloride) prior to surgical, endoscopic, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus (e.g., scaling, anesthesia prior to mucous membrane injections, before cauterization of mucous membranes).a p r s

May be used for vaginal or rectal procedures when considered feasible.p r

As an aerosol, may be used alone or as the fixed combination with butamben and tetracaine hydrochloride to control gagging.p r

Benzocaine Dosage and Administration

General

  • Benzocaine is commercially available (alone and in fixed combination with other drugs [e.g., antitussives, analgesics, demulcents, other local anesthetics]) in many dosage forms, some of which are intended for self-medication; consult manufacturer’s product labeling for complete directions for appropriate dosage and administration of the specific product.

Administration

Oral Administration

Administer orally as a lozenge.a e f t

Allow lozenge to slowly dissolve in the mouth.a e f

Otic Administration

Instill otic solution into the external ear canal.a n

Avoid touching the ear with the dropper.n

Following instillation of otic solution, moisten a cotton pledget with the drug and insert into the ear meatus.a n

Topical Administration to Mucous Membranes

Administer topically to mucosal membranes as an aerosol, liquid, gel, swab, disc, or solution; consult manufacturer’s product labeling for complete directions for appropriate application of the specific product.a b c d g h i j k l m r u

Avoid contact with the eye(s).b c d p r s u Not for injection.r s

Manufacturer of benzocaine in fixed combination with butamben and tetracaine hydrochloride (Cetacaine) recommends application directly to site where pain control is required; not necessary to dry tissue prior to application.r

Manufacturers of some topical benzocaine products intended for self-medication suggest that adults supervise children <12 years of age during drug administration.b c d g h i j k l m u

Aerosol

Benzocaine 20% aerosol spray: Apply to mucosal membrane area(s) for surgical or procedural anesthesia.p

Benzocaine 5% in fixed combination with glycerin 33% aerosol: For self-medication, apply 1 spray into throat or onto affected area.u Flammable; do not use near fire, flame, or heat.u

Gel, Liquid, Solution, or Swab

For self-medication, apply topically using cotton swab or finger according to manufacturer’s directions for the specific product.b c d g h i k l m s

Apply Cetacaine liquid (benzocaine, butamben, and tetracaine hydrochloride fixed combination) either directly to tissue or using a cotton applicator; if using applicator, do not hold applicator in position for an extended period, since local reactions to the anesthetics are related to length of time of application.r May apply liquid with cotton-tipped applicators or pellets, micro brushes, or with a sterile instrument (e.g., a Luer type syringe with a 20-gauge bent blunt needle tip).s

Cetacaine gel: Spread thinly and evenly over the application area.r

Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination): For dental procedures (e.g., scaling, pre-injection anesthesia), apply topical liquid in a continual line at the junction of the gum and tooth, in both buccal and lingual areas.s

Disc

Clean and dry affected oral area prior to administration.j Hold the disc on the affected area for 5–10 seconds, allowing saliva to moisten disc, which will then dissolve slowly in the mouth.j

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Administer the smallest amount required to produce the desired response.a

Benzocaine is commercially available (alone and in fixed combination with other drugs [e.g., antitussives, analgesics, demulcents, other local anesthetics]) in many dosage forms; consult manufacturer’s product labeling for appropriate dosage of the specific product.

Each 200 mg of Cetacaine aerosol, liquid, or gel contains 28 mg benzocaine, 4 mg butamben, and 4 mg tetracaine hydrochloride.r

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Analgesia/Anesthesia of Mucous Membranes
Oral

For self-medication in children ≥5 years of age: Generally, 1 lozenge (containing 10 or 15 mg benzocaine alone or in fixed combination with other drugs); repeat every 2 hours as necessary.a e f

Benzocaine 7.5-mg lozenge (in fixed combination with dextromethorphan 5 mg): For self-medication in children 6–12 years of age: 1 lozenge; repeat every 4 hours as needed up to 6 lozenges daily or as directed by a clinician.t

Benzocaine 7.5-mg lozenge (in fixed combination with dextromethorphan 5 mg): For self-medication in children ≥12 years of age: 2 lozenges (1 immediately after the other); repeat every 4 hours as necessary up to 12 lozenges daily or as directed by a clinician.t

Topical

Benzocaine 7.5% gel or swabs: For self-medication in infants ≥4 months of age, apply swab or a small amount (e.g., a pea-size amount) of gel to affected area up to 4 times daily or as directed by a dentist or clinician; do not use >7 days.k l

Benzocaine 10, 15, and 20% gel or liquid: For self-medication in children ≥2 years of age, apply up to 4 times daily to affected oral area(s) or as directed by a clinician or dentist; do not use >7 days.b c d g h i m

Benzocaine 5% aerosol (in fixed combination with glycerin 33%): For self-medication in children ≥3 years of age, apply 1 spray into throat or onto affected area up to 4 times daily or as directed by a clinician or dentist.u

Benzocaine 15-mg disc: For self-medication in children ≥2 years of age, apply 1 disc to affected oral area for 5–10 seconds, repeat every 2 hours as necessary or as directed by a dentist or clinician; do not use >7 days.j

Otic Pain
Otic

Benzocaine-antipyrine fixed combination: Instill into the ear canal permitting the solution to run along the wall of the canal until it is full; then, insert a cotton pledget moistened with the solution into the meatus.n May repeat every 1–2 hours if necessary.n

Cerumen Removal
Otic

Benzocaine-antipyrine fixed combination: Before removal of cerumen, instill solution 3 times daily for 2 or 3 days.n Following each dose, insert a cotton pledget moistened with the otic solution into the meatus.n

Following cerumen removal, may instill solution to aid in drying the ear canal or relieving discomfort.n Following each dose, insert a cotton pledget moistened with the otic solution into the meatus.n

Surgical/Procedural Local Anesthesia
Topical

Benzocaine 20%: No specific dosage recommendations in children, although manufacturer recommends dosage reduction in very young patients.p (See Adult Dosage.)

The manufacturer of Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination) states that an appropriate pediatric dosage has not been established.r

Adults

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Analgesia/Anesthesia of Mucous Membranes
Oral

For self-medication, generally, 1 lozenge (containing 10 or 15 mg benzocaine alone or in fixed combination with other drugs); repeat every 2 hours as necessary.a e f

Benzocaine 7.5-mg lozenge (in fixed combination with dextromethorphan 5 mg): For self-medication, 2 lozenges (1 immediately after the other); repeat every 4 hours as necessary up to 12 lozenges daily or as directed by a clinician.t

Topical

Benzocaine 10, 15, and 20% gel or liquid for self-medication: Apply to affected oral area up to 4 times daily or as directed by a clinician or dentist.b c d g h i m

Benzocaine 5% aerosol (in fixed combination with glycerin 33%): For self-medication, apply 1 spray into throat or onto affected area up to 4 times daily or as directed by a clinician or dentist.u

Benzocaine 15-mg disc: For self-medication, apply 1 disc to the affected oral area for 5–10 seconds, repeat every 2 hours as necessary or as directed by a dentist or clinician; do not use >7 days.j

Denture Irritation
Topical

Benzocaine 10, 15, or 20% gel or liquid: For self-medication, apply to affected oral area(s).b c m Do not reinsert dental work until irritation and/or pain is relieved or gel has dried; consult manufacturer’s product labeling for specific directions.b m

Otic Pain
Otic

Benzocaine-antipyrine fixed combination: Instill into the ear canal permitting the solution to run along the wall of the canal until it is full; then, insert a cotton pledget moistened with the solution into the meatus.n May repeat every 1–2 hours if necessary.n

Cerumen Removal
Otic

Benzocaine-antipyrine fixed combination: Before removal of cerumen, instill solution 3 times daily for 2 or 3 days.n Following each dose, insert a cotton pledget moistened with otic solution into the meatus.n

Following cerumen removal, may instill solution to aid in drying the ear canal or relieving discomfort.n Following each dose, insert a cotton pledget moistened with the otic solution into the meatus.n

Surgical/Procedural Local Anesthesia
Topical

Benzocaine 20% paste: Apply as needed.a

Benzocaine 20% aerosol: Prior to the procedure, 2–3 sprays to mucosal membrane area(s).p Do not exceed 5 sprays per use.p

Cetacaine aerosol (benzocaine, butamben, and tetracaine hydrochloride fixed combination): Spray onto site(s) for ≤1 second; at normal temperatures, the average expulsion rate is approximately 200 mg of solution per second.r Do not exceed 2 seconds.r

Cetacaine liquid (benzocaine, butamben, and tetracaine hydrochloride fixed combination): Apply 0.2 mL (approximately 6–7 drops; 200 mg of solution) with a cotton applicator or directly to the site(s).r Do not exceed 0.4 mL (approximately 12–14 drops).r (See Contraindications.)

Cetacaine gel (benzocaine, butamben, and tetracaine hydrochloride fixed combination): Apply 200 mg of gel (a bead approximately 13 mm in length and 5 mm in diameter) to site(s).r Do not exceed 400 mg (26 mm length and 5 mm diameter).r

Prescribing Limits

Pediatric Patients

Analgesia/Anesthesia of Mucous Membranes
Oral

Benzocaine 10- or 15-mg lozenges: Children ≥5 years of age: Maximum of 2 days for sore throat or 7 days for sore mouth.a e f

Benzocaine-dextromethorphan fixed-combination lozenge: Children 6–12 years of age: Maximum: 6 lozenges daily for a maximum of 2 days for sore throat or 7 days for sore mouth.t

Benzocaine-dextromethorphan fixed-combination lozenge: Children ≥12 years of age: Maximum: 12 lozenges daily for a maximum of 2 days for sore throat or 7 days for sore mouth.t

Topical

Benzocaine 7.5% gel or swab: Infants ≥4 months of age: Maximum 4 applications daily for 7 days.k l

Benzocaine 10, 15, or 20% gel or liquid: Children ≥2 years of age: Maximum 4 applications daily for 7 days.b c d g h i m

Benzocaine 15-mg disc: Children ≥2 years of age: Maximum 7 days.j

Benzocaine 5% aerosol (in fixed combination with glycerin 33%): For self-medication in children ≥3 years of age, maximum of 1 spray up to 4 times daily for up to 7 days.u

Adults

Analgesia/Anesthesia of Mucous Membranes
Oral

Benzocaine 10- or 15-mg lozenges: Maximum of 2 days for sore throat or 7 days for sore mouth.e f

Benzocaine-dextromethorphan fixed-combination lozenge: Maximum 12 lozenges daily for a maximum of 2 days for sore throat or 7 days for sore mouth.t

Topical

Benzocaine 10, 15, or 20% gel or liquid: Maximum 4 applications daily for 7 days.b c d g h i m

Benzocaine 15-mg disc: Maximum 7 days.j

Benzocaine 5% aerosol (in fixed combination with glycerin 33%): For self-medication, maximum of 1 spray up to 4 times daily for up to 7 days.u

Surgical/Procedural Local Anesthesia
Topical

Cetacaine aerosol spray (benzocaine, butamben, and tetracaine hydrochloride fixed combination): Do not spray >2 seconds.r

Cetacaine liquid (benzocaine, butamben, and tetracaine hydrochloride fixed combination): Do not apply >0.4 mL (12–14 drops).r

Cetacaine gel (benzocaine, butamben, and tetracaine hydrochloride fixed combination): Do not apply >400 mg (a bead approximately 26 mm in length and 5 mm in diameter).r

Benzocaine 20% aerosol: Maximum 5 sprays per use.p

Special Populations

Geriatric Patients

The manufacturers of benzocaine 20% aerosol and Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination) recommend reducing the dosage in debilitated geriatric patients.p r

Acutely Ill Patients

The manufacturers of benzocaine 20% aerosol and of Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination) recommend reducing the dosage in patients with an acute illness.p r

Cautions for Benzocaine

Contraindications

  • Known or suspected hypersensitivity to benzocaine, other ester-type local anesthetics, or any ingredient in the formulation.a b c d e f g h i j k l m n p r s t u

  • Otic solution: Perforated tympanic membrane.n

  • Benzocaine 20% aerosol and Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination) aerosol, liquid, and gel: Injection or use in eyes; patients with cholinesterase deficiency; application to large areas of denuded or inflamed tissue (excessive systemic absorption could result).p r Do not apply Cetacaine under dentures or cotton rolls (possible escharotic effect).r

Warnings/Precautions

Warnings

Serious Adverse Effects Associated with Local Anesthetics

Serious adverse effects (e.g., seizures, coma, irregular heartbeat, respiratory depression) reported following topical application of local anesthetics to skin; reported after application of extemporaneously compounded topical preparations containing high concentrations of anesthetics for cosmetic procedures and following use for FDA-approved indications.104 Use lowest concentration likely to be effective, and use in small amounts for shortest period possible; use of FDA-approved preparations recommended.104

Sensitivity Reactions

Tartrazine Sensitivity

Some commercially available formulations of benzocaine (e.g., Orajel Maximum Strength Liquid) contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.a h Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.a

Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, rarely reported.r

Possible dehydration of epithelium and escharotic effect; therefore, do not apply topical benzocaine under dentures or cotton rolls.r s

Possible localized allergic reactions or contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing; most common after prolonged or repeated use.r If rash, urticaria, edema, irritation, or other manifestations of allergy develop during therapy, discontinue the drug and consult a clinician.a b c g h i j k l m n r t Avoid prolonged use except under continual supervision.r

General Precautions

Methemoglobinemia

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Methemoglobinemia rarely reported after topical benzocaine application (e.g., in patients undergoing intubation or endoscopic or bronchoscopic procedures in hospitals); closely adhere to dosing recommendations.100 101 102 103 r s

Consider alternative preparations to benzocaine in patients at risk for complications related to methemoglobinemia (i.e., those with asthma, bronchitis, emphysema, or heart disease; smokers) and in patients who may be predisposed to methemoglobinemia (e.g., infants <4 months of age; older individuals with certain inborn defects [e.g., glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, NADH methemoglobin reductase deficiency, pyruvate kinase deficiency]).100

Observe patients receiving aerosol benzocaine preparations for signs of methemoglobinemia (pale, gray, or blue colored skin, headache, lightheadedness, dyspnea, anxiety, fatigue, tachycardia).100 r Promptly treat patients who develop cyanosis or methemoglobinemia (e.g., administer methylene blue if appropriate). 100 r

Infection

Use of otic anesthetics may mask symptoms of a fulminating middle ear infection (acute otitis media).a

Self-Medication

When used for self-medication for mouth soreness, discontinue the drug and consult a clinician if the condition worsens or symptoms persist for >7 days or resolve and occur again within a few days.b c d e f i j k l m t

When used for self-medication for sore throat, discontinue the drug and consult a clinician if sore throat is severe, persists for >2 days, or is accompanied or followed by fever, headache, rash, pain, redness, swelling, nausea, or vomiting .a b c e f t

Fixed-Combination Preparations

When used in fixed combination with other drugs (e.g., antitussives, analgesics, demulcents, other local anesthetics), consider the cautions, precautions, and contraindications associated with the other drug(s).d e f i m n r t

Specific Populations

Pregnancy

Category C.n r

Lactation

Not known whether benzocaine is distributed into human milk;n caution advised if otic preparation is used in nursing women.n

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Safety and efficacy of topical benzocaine 7.5% gel and teething swabs for self-medication have not been established in children <4 months of age.k l

Safety and efficacy of topical benzocaine (10, 15, and 20%) gel and liquid or 15-mg discs for self-medication not established in children <2 years of age; use only under the direction of a clinician.b c d g h i j m

Safety and efficacy of benzocaine lozenges for self-medication have not been established in children <5 years of age; consult a clinician.e f

Safety and efficacy of benzocaine-dextromethorphan lozenges for self-medication in children <6 years of age have not been established; consult a clinician.t

Otic solution: Manufacturer of fixed combination of benzocaine and antipyrine makes no specific recommendations regarding use in pediatric patients.n o Consult a clinician.o

Benzocaine 20% aerosol: Manufacturer makes no specific recommendations regarding use in pediatric patients but recommends dosage reduction in very young patients.p

Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination); appropriate pediatric dosage not established.r

Common Adverse Effects

Generally nontoxic when applied topically, but sensitization and methemoglobinemia may occur.a s (See Warnings/Precautions under Cautions.)

Benzocaine Pharmacokinetics

Absorption

Onset

Following Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination) gel, liquid, or spray administration, anesthesia occurs within 30 seconds to 1 minute.r s

Duration

Following topical application of benzocaine 20% aerosol, anesthesia lasts approximately 15 minutes.p

Following Cetacaine (benzocaine, butamben, and tetracaine hydrochloride fixed combination) gel, liquid, or spray administration, anesthesia lasts approximately 30–60 minutes.r s

Stability

Storage

Oral

Lozenges

20–25°C.e f t Protect from humidity.e f t

Topical

Disc

15–30°C under dry conditions.j

Gel and Liquid

20–25°C.b c d Do not refrigerate.b

Aerosol

20% aerosol: Room temperature (<49°C).p q

5% aerosol with glycerin 33%: 20–25°C.u Do not freeze.u

Otic

Solution

Benzocaine-antipyrine otic solution: 15–30°C.n Protect from light and heat.n

Actions

  • Alleviates pain and discomfort.b c d e f g h i j k l m n t u

  • Believed to act by reversibly blocking nerve conduction.r

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of discontinuing therapy and consulting clinician if swelling, rash, irritation, or fever develops during therapy.b c e f g h i j k l m n r t

  • Importance of avoiding contact with the eyes.b c d r s u

  • Importance of using as directed and not applying topical preparations in large quantities, particularly over raw surfaces or blistered areas.r s

  • Advise patients using benzocaine preparations for self-medication not to exceed the recommended dosage or duration of therapy and to read carefully the manufacturer’s product labeling; importance of following directions for appropriate dosage and administration.a b e f g h i j k l m t u

  • Advise patients using benzocaine for self-medication of mouth soreness to discontinue the drug and consult a clinician if symptoms do not improve after 7 days or if irritation, pain, or redness persists or worsens.b c d e f g h i j k l m t

  • Advise patients using benzocaine for self-medication of sore throat to consult a clinician if sore throat is severe, persists for >2 days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.e f t

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.n r u

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.r

  • Otic solution: Advise patients not to rinse dropper after use.n Instead, insert dropper assembly back into container without compressing the rubber bulb, and tightly screw assembly into container.n

  • Otic solution: Importance of not using the solution if it becomes brown or contains a precipitate.n

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Benzocaine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Lozenges

15 mg

Mycinettes

Pfeiffer

Topical

Aerosol

20%

Hurricaine Spray (with or without disposable extension tube)

Beutlich

Topex Metered Spray (with disposable extension tube)

Sultan

Disc

15 mg

Orajel Protective Mouth Sore Discs

Del

Gel

7.5%

Anbesol Baby (with parabens)

Wyeth

Baby Orajel Teething Pain Medication

Del

10%

Anbesol Regular Strength (with benzyl alcohol, propylene glycol, and methylparaben)

Wyeth

Baby Orajel Nighttime Formula

Del

Orajel Regular Strength

Del

Zilactin-B Medicated Gel with Benzocaine

Zila

20%

Anbesol Maximum Strength (with benzyl alcohol, propylene glycol, and methylparaben)

Wyeth

Hurricaine

Beutlich

Orabase-B

Colgate Oral

Orajel Maximum Strength

Del

Orajel Mouth-Aid (with benzalkonium chloride, povidone, propylene glycol,and zinc chloride)

Del

Topex

Sultan

Paste

20%

Orabase-B Maximum Strength

Colgate Oral

Solution

2.5%

Babee Teething Lotion (with cetalkonium chloride)

Pfeiffer

10%

Anbesol Regular Strength (with benzyl alcohol, propylene glycol, and methylparaben)

Wyeth

Orajel Regular Strength Liquid (with alcohol 44.2%)

Del

20%

Anbesol Maximum Strength (with benzyl alcohol, propylene glycol, and methylparaben)

Wyeth

Hurricaine

Beutlich

Orajel Maximum Strength Liquid (with alcohol 44.2% and tartrazine)

Del

Topex

Sultan

Swab

7.5%

Baby Orajel Teething Swabs

Del

20%

Orajel Medicated Cold Sore Swabs (with tartrazine)

Del

Orajel Medicated Mouth Sore Swabs (with tartrazine)

Del

Antipyrine and Benzocaine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Otic

Solution

5.4% Antipyrine and Benzocaine 1.4%

A/B Otic

Perrigo

Allergen Ear Drops

Teva

Antipyrine and Benzocaine Otic Solution

Bausch & Lomb, Taro

Auroto

Actavis

Other Benzocaine Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Lozenges

7.5 mg with Dextromethorphan Hydrobromide 5 mg

Cepacol Sore Throat + Cough Relief (with propylene glycol)

Combe

10 mg with Menthol 2.1 mg

Cepacol Sore Throat with Pain Numbing Relief

Combe

15 mg with Pectin 5 mg

Cepacol Sore Throat + Coating

Combe

Topical

Aerosol

5% with Glycerin 33%

Cepacol Dual Relief

Combe

14% with Butamben 2% and Tetracaine Hydrochloride 2%

Cetacaine (with benzalkonium chloride)

Cetylite

Gel

14% with Butamben 2% and Tetracaine Hydrochloride 2%

Cetacaine (with benzalkonium chloride)

Cetylite

15% with Menthol 2%

Orajel Denture Plus (with alcohol 66.7%)

Del

Orajel Ultra Mouth Sore Medicine Film-Forming

Del

20% with Allantoin 0.5%, Camphor 3%, Dimethicone 2%, and White Petrolatum 65%

Orajel Multi-Action Cold Sore Medicine

Del

20% with Allantoin 1%, Camphor 3%, and White Petrolatum 64.9%

Anbesol Cold Sore Therapy (with benzyl alcohol and parabens)

Wyeth

Solution

14% with Butamben 2% and Tetracaine Hydrochloride 2%

Cetacaine (with benzalkonium chloride)

Cetylite

20% w/v with Benzocaine Tincture Compound

Kanka-A

Blistex

Sponge/Brush

20% with Allantoin 0.5%, Camphor, Dimethicone 2%, and White Petrolatum 65%

Orajel Medicated Cold Sore Brush (with propylene glycol)

Del

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Antipyrine-Benzocaine 5.4-1.4% Solution (BAUSCH &amp; LOMB): 10/$46.06 or 20/$53.12

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 7, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Food and Drug Administration. FDA Public Health Advisory: Benzocaine sprays marketed under different names, including Hurricane, Topex, and Cetacaine. 2006 Feb 10. From FDA website.

101. Institute for Safe Medication Practices. ISMP Medication Safety Alert: Benzocaine-containing topical sprays and methemoglobinemia. 2002 Oct 3. From Institute for Safe Medication Practices website.

102. Food and Drug Administration. FDA Patient Safety News: Anesthetic sprays and methemoglobinemia. 2003 Jan. From FDA website.

103. Moore TJ, Walsh CS, Cohen MR. Reported adverse event cases of methemoglobinemia associated with benzocaine products. Arch Intern Med. 2004; 164:1192-6. [PubMed 15197044]

104. Food and Drug Administration. FDA Public Health Advisory: Life-threatening side effects with use of skin products containing numbing ingredients for cosmetic procedures. 2007 Feb 6, updated 2007 Feb 9. From FDA website.

a. AHFS Drug Information 2007. McEvoy GK, ed. Benzocaine. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2844-5.

b. Wyeth Pharmaceuticals. Anbesol (benzocaine 20%) gel patient information. Madison, NJ; 2007.

c. Wyeth Pharmaceuticals. Anbesol (benzocaine 20%) liquid patient information. Madison, NJ; 2007.

d. Wyeth Pharmaceuticals. Anbesol cold sore therapy patient information. Madison, NJ; 2007.

e. Combe Inc. Cepacol (benzocaine-pectin) sore throat + coating relief oral lozenges patient information. White Plains, NY; undated.

f. Combe Inc. Cepacol (benzocaine-menthol) sore throat with pain numbing relief oral lozenges patient information. White Plains, NY; undated.

g. Del Pharmaceuticals. Orajel (benzocaine 10%) regular strength gel patient information. Uniondale, NY; 2007.

h. Del Pharmaceuticals. Orajel (benzocaine 20%) maximum strength liquid patient information. Uniondale, NY; 2007.

i. Del Pharmaceuticals. Orajel (benzocaine-menthol) ultra mouth sore medicine film-forming gel patient information. Uniondale, NY; 2007.

j. Del Pharmaceuticals. Orajel (benzocaine) protective mouth sore discs patient information. Uniondale, NY; 2007.

k. Del Pharmaceuticals. Baby Orajel (benzocaine 7.5%) teething pain medicine gel patient information. Uniondale, NY; 2007.

l. Del Pharmaceuticals. Baby Orajel (benzocaine 7.5%) teething swabs patient information. Uniondale, NY; 2007.

m. Del Pharmaceuticals. Baby Orajel (benzocaine-menthol) denture plus patient information. Uniondale, NY; 2007.

n. Perrigo. A/B otic drops solution (benzocaine and antipyrine) prescribing information. Allegan, MI; 2006.

o. Perrigo Co. Allegan, MI: Personal communication.

p. Sultan Healthcare. Topexmetered spray (benzocaine 20%) prescribing information. Englewood, NJ; 2006.

q. Sultan Healthcare. Englewood, NJ: Personal communication.

r. Cetylite Industries. Cetacaine (benzocaine 14% , tetracaine 2% and butamben 2%) spray, gel and liquid prescribing information. Pennsauken, NJ; 2006 Sept.

s. Cetylite Industries. Cetacaine (benzocaine 14% , tetracaine 2% and butamben 2%) spray, gel and liquid product information. Pennsauken, NJ; 2007 Mar.

t. Combe Inc. Cepacol (benzocaine-dextromethorphan) sore throat + cough relief oral lozenges patient information. White Plains, NY: Undated.

u. Combe Inc. Cepacol Sore Throat Dual Relief Spray package insert. White Plains, NY; 2007 May.

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