Skip to Content
Be ready for a severe allergy emergency. Read more >>

Benzocaine eent

Pronunciation

Class: Local Anesthetics
ATC Class: R02AD01
VA Class: OR900
CAS Number: 94-09-7
Brands: Anbesol, Anbesol Cold Sore Therapy, Cepacol, Cetacaine, Hurricaine, Kanka-A, Orajel, Topex

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

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

Has been used alone or in fixed combination with antipyrine for the temporary relief of ear pain (otalgia, earache) associated with otitis media of various causes.a n Efficacy and safety for ear pain relief not established.107 a (See Preparations.)

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

Has been used to facilitate the removal of excessive or impacted cerumen (earwax).n Efficacy and safety not established.107 (See Preparations.)

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

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 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

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

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, 10, 15, and 20% gel, swabs, 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 k l 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

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

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

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

  • 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

Methemoglobinemia rarely reported after topical benzocaine application, mostly in patients undergoing intubation or endoscopic or bronchoscopic procedures in hospitals, but also following topical application of OTC preparations to oral mucosa; closely adhere to dosing recommendations.100 101 102 103 105 106 r s

Manifestations of methemoglobinemia (e.g., pale, gray, or blue colored skin, lips, or nail beds; headache, lightheadedness, anxiety, confusion, or fatigue; tachycardia; dyspnea, increased respiratory rate, or decreased blood oxygen saturation) may occur within minutes to 1–2 hours following application.100 105 106

Concomitant ingestion or use of nitrite- or nitrate-containing products (e.g., foods, drugs) may be additive in inducing methemoglobin formation.105 106

Patients with asthma, bronchitis, emphysema, or heart disease and those who smoke may be at risk for methemoglobinemia-related complications; infants <4 months of age, geriatric adults, and individuals with certain inborn defects (e.g., glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, NADH methemoglobin reductase deficiency, pyruvate kinase deficiency) may be predisposed to methemoglobinemia.100 105 106

Development of methemoglobinemia following topical oropharyngeal administration of benzocaine aerosols may not be related to the amount applied; may occur following a single spray or following excessive use.105 Amount of benzocaine contained in a single spray varies among preparations and depends on the solution concentration, amount of time the actuator is depressed, residual volume in the can, and spatial orientation of the can during administration.105

Observe patients receiving aerosol benzocaine preparations for signs of methemoglobinemia during the medical procedure and for ≥2 hours after benzocaine administration.100 105 r May obtain a direct measure of methemoglobin through cooximetry (arterial blood gas and pulse oximetry are unreliable).100 103 105 106 Promptly treat patients who develop cyanosis or methemoglobinemia (e.g., administer methylene blue if appropriate).100 r

Development of methemoglobinemia reported with various strengths of benzocaine gels and liquids, including concentrations as low as 7.5%; may occur with first application to oral mucosa or after additional use.106 Most reported cases involved children <2 years of age who received the gel for teething; however, cases also reported in adults using the gel or liquid for relief of toothache.106

FDA states that benzocaine preparations should not be used on children <2 years of age, except under the advice and supervision of a clinician.106 Adults who use benzocaine gels or liquids to relieve mouth pain should follow the product labeling.106 FDA states that benzocaine gels and liquids should be used sparingly, only when needed, and not more than 4 times daily.106 (See Advice to Patients.)

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

Pediatric Use

Safety and efficacy of topical benzocaine (7.5, 10, 15, and 20%) gel, swabs, 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 k l 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

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

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

  • Before recommending use of benzocaine preparations, inform patients or caregivers of the signs and symptoms of methemoglobinemia and advise them to seek immediate medical attention if such manifestations occur.106 Advise patients to store benzocaine preparations out of reach of children.106

  • 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

  • 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

Wyeth

Baby Orajel Teething Pain Medication

Del

10%

Anbesol Regular Strength

Wyeth

Baby Orajel Nighttime Formula

Del

Orajel Regular Strength

Del

Zilactin-B Medicated Gel with Benzocaine

Zila

20%

Anbesol Maximum Strength

Wyeth

Hurricaine

Beutlich

Orabase-B

Colgate Oral

Orajel Maximum Strength

Del

Orajel Mouth-Aid

Del

Topex

Sultan

Paste

20%

Orabase-B Maximum Strength

Colgate Oral

Solution

2.5%

Babee Teething Lotion

Pfeiffer

10%

Anbesol Regular Strength

Wyeth

Orajel Regular Strength Liquid

Del

20%

Anbesol Maximum Strength

Wyeth

Hurricaine

Beutlich

Orajel Maximum Strength Liquid

Del

Topex

Sultan

Swab

7.5%

Baby Orajel Teething Swabs

Del

20%

Orajel Medicated Cold Sore Swabs

Del

Orajel Medicated Mouth Sore Swabs

Del

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

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

Cetylite

Gel

14% with Butamben 2% and Tetracaine Hydrochloride 2%

Cetacaine

Cetylite

15% with Menthol 2%

Orajel Denture Plus

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

Wyeth

Solution

14% with Butamben 2% and Tetracaine Hydrochloride 2%

Cetacaine

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

Del

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions July 20, 2016. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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.

105. Food and Drug Administration. FDA drug safety communication: FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures. 2011 Apr 7. From FDA website.

106. Food and Drug Administration. FDA drug safety communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth. 2011 Apr 7. From FDA website.

107. Food and Drug Administration. Unapproved and misbranded otic prescription drug products; enforcement action dates. Notice. [Docket No. FDA-2015-N-2008]. Fed Regist. 2015; 80:38212-6.

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. Church & Dwight. Orajel (benzocaine 7.5%) medicated teething gel patient information. Ewing, NJ; undated.

l. Church & Dwight. Orajel (benzocaine 7.5%) medicated teething swabs patient information. Ewing, NJ; undated.

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.

Hide