Benzocaine is used in the form of oral lozenges for the temporary relief of minor sore throat pain or in the form of topical aerosols, gels, creams, ointments, or solutions for the temporary relief of pain associated with various oral or dental conditions (e.g., toothache, sore gums, orthodontic appliances, denture irritation, cold sores, ulcerations, canker sores, minor injury/irritation); benzocaine is commercially available in a variety of over-the-counter (OTC) preparations as a single entity or in fixed combination with other drugs (e.g., dextromethorphan, menthol) for self-medication of these conditions.111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 124, 126, 130 However, FDA states that OTC benzocaine products are associated with serious risk (e.g., methemoglobinemia) and provide little to no benefit in treating oral pain.108 (See Methemoglobinemia under Cautions: Precautions and Contraindications.) Benzocaine or other local anesthetics should not be used for the treatment of teething pain in infants because such therapy is not useful and is associated with a risk of methemoglobinemia that outweighs any potential benefit of the drug.108, 109, 111, 112, 117 Because of the risk of methemoglobinemia, OTC benzocaine preparations should not be used in infants and children younger than 2 years of age and should be used sparingly and only as needed in adults and children 2 years of age or older.108, 109
Benzocaine also has been used topically in the form of aerosols, gels, or solutions for local anesthesia† of oral and other accessible mucous membranes (except the eyes).125, 127, 128, 129 The fixed-combination preparation containing benzocaine, butamben, and tetracaine hydrochloride (Cetacaine®) has been used topically for local anesthesia prior to surgical, endoscopic, or other medical procedures; the aerosol formulation also has been used for suppressing the gag reflex†.127, 128, 129 However, FDA states that benzocaine is not approved for these uses.108 (See Methemoglobinemia under Cautions: Precautions and Contraindications.)
Benzocaine (in fixed combination with antipyrine) has been used topically in the external auditory canal for the temporary relief of ear pain† associated with acute otitis media of various causes.123 Topical anesthetics may provide symptomatic relief, but they do not preclude the need for appropriate anti-infective therapy when ear pain is secondary to infection. The efficacy and safety of benzocaine for relief of ear pain have not been established.107, 123 The fixed combination of benzocaine and antipyrine also has been used topically in the external auditory canal to facilitate removal of excessive or impacted cerumen (earwax)†; however, efficacy and safety of the drug for this use have not been established.107, 123
For other uses of benzocaine as a topical anesthetic, see 84:08.
Benzocaine is administered orally as a lozenge or applied topically to mucous membranes as an aerosol spray, swab, gel, solution, cream, or ointment.111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 124, 127, 128, 129 The drug should not be administered as an injection.127, 128, 129 Benzocaine is commercially available alone or 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 ; the manufacturer's product labeling should be consulted for complete directions for appropriate dosage and administration of the specific product. The smallest amount required to produce the desired response should be administered.108
Benzocaine lozenges are administered orally by dissolving the lozenge slowly in the mouth.114, 115, 124
For topical application, benzocaine may be applied to any accessible mucous membrane except for the eyes.111, 112, 113, 125, 127, 128, 129
When using aerosol preparations, the amount of benzocaine contained in a single spray varies based on the concentration of the solution, amount of time the actuator is depressed, residual volume in the can, and spatial orientation of the can during administration.105
The manufacturer of benzocaine in fixed combination with butamben and tetracaine hydrochloride (Cetacaine®) recommends application directly to the site where pain control is required; it is not necessary to dry the tissue prior to application.127, 128, 129
The manufacturers of some topical benzocaine products intended for self-medication suggest that adults supervise children younger than 12 years of age during drug administration.111, 112, 113, 116, 118
For the temporary relief of minor sore throat pain, 1 or 2 benzocaine-containing lozenges are dissolved slowly in the mouth and repeated every 2 or 4 hours as necessary depending on the amount of benzocaine contained in each lozenge.114, 115, 124, 126 When using preparations containing 15 mg of benzocaine, the recommended dosage in adults and children 3 years of age or older is 1 lozenge every 2 hours as needed.115, 124 When using preparations containing 6 or 7.5 mg of benzocaine, the recommended dosage in adults and children 12 years of age or older is 2 lozenges every 4 hours as needed (up to 12 lozenges in 24 hours) and the recommended dosage in children 6-12 years of age is 1 lozenge every 4 hours as needed (up to 6 lozenges in 24 hours).114, 126 Benzocaine lozenges should not be used for self-medication of sore throat for longer than 2 days.114, 115, 126 Because of the potential risk of methemoglobinemia, FDA states that benzocaine-containing preparations should not be used in children younger than 2 years of age, and should be used sparingly (no more than 4 times a day) and only as needed in adults and children 2 years of age or older.108 (See Methemoglobinemia under Cautions: Precautions and Contraindications.)
For local anesthesia† of accessible oral mucous membranes, preparations containing 14 or 20% benzocaine are applied directly to the site where pain control is needed.125, 127, 128, 129
Each 200 mg of Cetacaine® aerosol, liquid, or gel contains 28 mg benzocaine, 4 mg butamben, and 4 mg tetracaine hydrochloride.127, 128, 129 If Cetacaine® aerosol is used, the drug should be sprayed directly to the tissue for 1 second or less; at normal temperatures, the average expulsion rate is approximately 200 mg of solution per second.129 The spray should not be applied for more than 2 seconds.129 If Cetacaine® liquid is used, approximately 0.2 mL (200 mg of solution) should be applied directly to the site with a cotton or brush applicator; no more than 0.4 mL (400 mg) should be used.127 For dental procedures (e.g., scaling, pre-injection anesthesia), the topical liquid should be applied drop-wise into periodontal pockets using the syringe and delivery device supplied by the manufacturer.127 For surface application to mucosal membranes, a single dip of the topical liquid should be applied directly to the site with a cotton or brush applicator.127 To minimize the risk of local reactions, the applicator should not be held in position for an extended period.127 If Cetacaine® gel is used, 200 mg (a bead approximately 0.2-0.5 inches long) should be applied directly to the site in a thin and even layer with a cotton swab; no more than 400 mg should be used.128 Dosage should be reduced in debilitated geriatric patients, acutely ill patients, and very young patients.127, 128, 129
For self-medication to provide temporary relief of pain associated with various oral or dental conditions, preparations containing 10-20% benzocaine (as a gel, ointment, cream, swab, solution, or aerosol spray) are applied topically up to 4 times a day to the affected area as needed.111, 112, 113, 116, 117, 118, 119, 120, 121, 122, 130 Benzocaine 20% aerosol should be sprayed for 0.5 seconds by pressing and immediately releasing the actuator; a repeat spray may be administered if necessary.130 Preparations intended for self-administration should not be used for more than 7 days unless directed by a clinician or dentist.111, 112, 113, 116, 117, 118, 119, 120, 121, 122, 130 Because of the potential risk of methemoglobinemia, FDA states that benzocaine-containing preparations should not be used in children younger than 2 years of age, and should be used sparingly (no more than 4 times a day) and only as needed in adults and children 2 years of age or older.108 (See Methemoglobinemia under Cautions: Precautions and Contraindications.)
When applied topically as recommended, benzocaine is relatively nontoxic; however, sensitization and methemoglobinemia may occur. (See Cautions: Precautions and Contraindications.)
Serious adverse effects (e.g., seizures, coma, irregular heart beat, respiratory depression) have been reported following topical application of local anesthetics to the skin.104 These events have occurred following application of extemporaneously prepared topical preparations containing high concentrations of anesthetics for cosmetic procedures and following use for indications approved by the FDA.104 (See Cautions in Benzocaine 84:08.)
Precautions and Contraindications
Methemoglobinemia, a rare but serious blood disorder, has occurred following topical application of benzocaine.100, 101, 102, 103, 105, 106, 108 FDA has been closely monitoring this safety risk since 2006 and estimates that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to date.108 Most cases have occurred in patients receiving aerosol preparations of benzocaine during medical procedures (e.g., intubation, endoscopic, or bronchoscopic procedures), but methemoglobinemia also has occurred following topical application of nonprescription (over-the-counter, OTC) preparations of benzocaine for relief of oral or dental conditions.103, 105, 106, 108 In 2006, FDA issued the first public health advisory regarding the risk of methemoglobinemia with use of benzocaine-containing aerosol preparations during medical procedures involving the larynx or pharynx.100, 108, 110 Since the initial notification, FDA has continued to receive reports of methemoglobinemia, including several fatal cases, associated with such use of aerosol benzocaine preparations as well as cases associated with topical application of OTC gel and liquid formulations of the drug.105, 106, 108
Patients receiving benzocaine-containing products should be monitored for signs and symptoms 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), which may occur within minutes to 1-2 hours following application of benzocaine.100, 105, 106, 108 Concomitant ingestion or use of nitrite- or nitrate-containing products (e.g., foods, drugs) may have additive effects in inducing methemoglobin formation.105, 106, 108 Patients with asthma, bronchitis, emphysema, or heart disease and those who smoke may be at greater risk for complications related to methemoglobinemia, and infants younger than 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 development of methemoglobinemia.100, 105, 106, 108
The development of methemoglobinemia following topical oropharyngeal administration of aerosol preparations of benzocaine is not dose related, as methemoglobinemia has occurred following a single spray or following excessive use.105, 108 The amount of benzocaine contained in a single spray varies among preparations and depends on the concentration of the solution, amount of time the actuator is depressed, residual volume in the can, and spatial orientation of the can during administration.105 Patients receiving aerosol preparations containing benzocaine should be observed for signs of methemoglobinemia during the medical procedure and for at least 2 hours after benzocaine administration.100, 105 A direct measure of methemoglobin may be obtained through cooximetry (arterial blood gas and standard 2-wavelength pulse oximetry are unreliable).100, 103, 105, 106, 108 Lidocaine is less likely to form methemoglobin and may be a safer alternative to benzocaine for topical anesthetic use.108, 110
Methemoglobinemia has been reported with various strengths of benzocaine gels and liquids, including concentrations as low as 7.5% (not commercially available in the US), and may occur with the first application of benzocaine to the oral mucosa or after additional use.106, 108 Most reported cases have occurred in children 2 years of age or younger who received benzocaine gel for teething; however, cases also have been reported in adults who applied benzocaine gel or liquid to the oral mucosa for relief of toothache.106 FDA states that benzocaine preparations should not be used for teething pain in infants; parents and/or other caregivers should follow alternative treatment strategies recommended by the American Academy of Pediatrics (e.g., rubbing or massaging gums with fingers, using a firm rubber teething ring).108, 109 Adults experiencing mouth sores or pain should follow treatment strategies recommended by the American Dental Association.108
FDA states that benzocaine preparations should not be used in children younger than 2 years of age and should be used sparingly, only when needed, and not more than 4 times daily in adults and children 2 years of age or older.108 Before recommending use of benzocaine-containing preparations, clinicians should inform patients or caregivers of the signs and symptoms of methemoglobinemia and advise them to seek immediate medical attention if such manifestations occur.106, 108 Patients who develop methemoglobinemia should be promptly treated.100 Benzocaine preparations should be stored out of reach of children.106, 108
Serious Adverse Effects Associated with Local Anesthetics
Serious adverse effects have occurred following topical application of local anesthetic preparations to the skin.104 When a topical anesthetic is needed for a procedure, use of a preparation approved by the FDA has been recommended.104 A preparation containing the lowest concentration of anesthetic likely to be effective should be used; a small amount of topical anesthetic should be applied to the affected area for the shortest period necessary for the desired effect.104 When the topical anesthetic will be applied by the patient, the patient should apply the topical preparation as directed by a clinician.104
Other Precautions and Contraindications
Some commercially available formulations of benzocaine (e.g., Orajel® Double Medicated Toothache and Gum Relief Plus Liquid, Orajel® Mouth Sore Swabs) contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.119, 121 Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.
Topical benzocaine preparations should not be used in individuals with known or suspected hypersensitivity to the drug, other ester-type local anesthetics, or any ingredient in the formulation. Possible localized allergic reactions or contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing may occur with benzocaine, most commonly after prolonged or repeated use.127 If rash, urticaria, edema, irritation, or other manifestations of allergy develop, the drug should be discontinued and a clinician consulted.111, 112, 116, 117, 118, 119, 120
Topical benzocaine preparations are not intended for prolonged use. Patients using topical benzocaine preparations for self-medication should be advised not to exceed the recommended dosage or duration of therapy. If the condition persists or irritation develops, the drug should be discontinued and a clinician or dentist consulted.
When preparations containing benzocaine in fixed combination with other drugs are used, the usual cautions, precautions, and contraindications associated with the other drug(s) should be considered.113, 114, 115, 118, 120, 121, 122, 127
Contraindications to the use of Cetacaine® (benzocaine, butamben, and tetracaine hydrochloride fixed combination) include injection or use in the eyes; use in patients with cholinesterase deficiency; and application to large areas of denuded or inflamed tissue (excessive systemic absorption could result).127, 128, 129 Cetacaine® should not be applied under dentures or cotton rolls because of a possible escharotic effect.127, 128, 129
Benzocaine is a local anesthetic of the ester type. Benzocaine occurs as small, white crystals or as a white, crystalline powder, is odorless, and is very slightly soluble in water and freely soluble in alcohol.
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Lozenges | 15 mg | Chloraseptic® Warming Sore Throat Lozenges | |
Topical | Aerosol | 20% | Americaine® Anesthetic Spray | |
Hurricaine® Spray | ||||
Topex® Metered Spray | ||||
Gel | 10% | Anbesol® Regular Strength Gel | ||
Orajel® Regular Mild Toothache Relief Medicated Gel | ||||
Zilactin®-B | ||||
20% | Anbesol® Maximum Strength Gel | Wyeth | ||
Hurricaine® | Beutlich | |||
Topex® | Sultan | |||
Solution | 10% | Anbesol® Regular Strength Liquid | Wyeth | |
20% | Anbesol® Maximum Strength Liquid | Wyeth | ||
Hurricaine® | Beutlich | |||
Topex® | Sultan | |||
Swab | 20% | Orajel® Maximum Toothache and Oral Pain Relief Swabs | Church and Dwight | |
Orajel® Mouth Sore Swabs | Church and Dwight |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Lozenges | 6 mg with Menthol 10 mg | Chloraseptic® Sore Throat | Prestige Consumer |
6 mg with Menthol 10 mg and Dextromethorphan Hydrobromide 5 mg | Chloraseptic® Sore Throat and Cough | Prestige Consumer | ||
7.5 mg with Dextromethorphan Hydrobromide 5 mg | Cepacol® Extra Strength Sore Throat and Cough | |||
15 mg with Menthol 2.3 mg | Cepacol® Extra Strength Sore Throat | Reckitt Benckiser | ||
15 mg with Menthol 2.5 mg | Cepacol® Extra Strength Sore Throat | Reckitt Benckiser | ||
15 mg with Menthol 3.6 mg | Cepacol® Extra Strength Sore Throat | Reckitt Benckiser | ||
15 mg with Menthol 10 mg | Chloraseptic® Max Sore Throat | Prestige Consumer | ||
15 mg with Menthol 20 mg | Cepacol® Instamax Sore Throat | Reckitt Benckiser | ||
Topical | Aerosol | 14% with Butamben 2% and Tetracaine Hydrochloride 2% | Cetacaine® Topical Anesthetic Spray | |
20% with Benzethoniuim Chloride 0.2% | Dermoplast® First Aid Spray | |||
20% with Menthol 0.5% | Dermoplast® Pain Relieving Spray | Moberg | ||
Cream | 20% with Menthol 0.25% and Zinc Chloride 0.15% | Orajel® Severe PM Toothache and Gum Relief Plus Triple Medicated Cream | Church and Dwight | |
20% with Menthol 0.5% and Zinc Chloride 0.15% | Orajel® Severe Toothache and Gum Relief Plus Triple Medicated Cream | Church and Dwight | ||
20% with Allantoin 0.5%, Camphor 3%, Dimethicone 2%, Menthol 1%, and White Petrolatum 64% | Orajel® Moisturelock Cold Sore Symptom Treatment | Church and Dwight | ||
Gel | 14% with Butamben 2% and Tetracaine Hydrochloride 2% | Cetacaine® Topical Anesthetic Gel | Cetylite | |
20% with Benzalkonium Chloride 0.02% and Zinc Chloride 0.1% | Orajel® Mouth Sore Gel | Church and Dwight | ||
20% with Menthol 0.26% | Orajel® Maximum Toothache Relief Double Medicated Gel | Church and Dwight | ||
20% with Menthol 0.5% and Zinc Chloride 0.15% | Orajel® Severe Toothache and Gum Relief Plus Triple Medicated Gel | Church and Dwight | ||
20% with Menthol 0.7% and Zinc Chloride 0.15% | Orajel® for Denture Pain Triple Medicated Gel | Church and Dwight | ||
Ointment | 20% with Allantoin 1%, Camphor 3%, and White Petrolatum 64.9% | Anbesol® Cold Sore Therapy | Wyeth | |
Solution | 5% with Benzalkonium Chloride 0.13% | Orajel® Touch-free Cold Sore Patented Treatment | Church and Dwight | |
14% with Butamben 2% and Tetracaine Hydrochloride 2% | Cetacaine® Topical Anesthetic Liquid | Cetylite | ||
20% w/v with Benzoin Tincture Compound | Kank-A® Mouth Pain Liquid | |||
20% with Menthol 0.1% | Orajel® Severe Toothache and Gum Relief Plus Double Medicated Liquid | Church and Dwight |
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. [Web]
102. Food and Drug Administration. FDA Patient Safety News: Anesthetic sprays and methemoglobinemia. 2003 Jan. From FDA website. [Web]
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. [Web]
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. [Web]
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. [Web]
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.
108. Food and Drug Administration. FDA drug safety announcement: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. 2018 May 23. From FDA website. [Web]
109. The American Academy of Pediatrics. Teething: 4 to 7 months. 2016 Oct 6. From FDA website. [Web]
110. Department of Health and Human Services, Food and Drug Administration. Use of ozone-depleting substances. Proposed Rule. [21 CFR Part 2] Fed Regist 2016; 81:74368-72. [Web]
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112. Wyeth Consumer Healthcare. Anbesol® (benzocaine 20%) maximum strength liquid drug facts. Madison, NJ; 2018.
113. Wyeth Consumer Healthcare. Anbesol® cold sore therapy drug facts. Madison, NJ; 2018 Sept.
114. Reckitt Benckiser. Cepacol® (benzocaine and dextromethorphan hydrobromide) sore throat and cough oral lozenges patient information. Parsipanny, NJ; 2016 June.
115. Reckitt Benckiser. Cepacol® (benzocaine and menthol) sore throat oral lozenges patient information. Parisappany, NJ; 2016 June.
116. Church and Dwight. Orajel® (benzocaine 10%) regular mild toothache relief medicated gel drug facts. Ewing, NJ; 2018.
117. Wyeth Consumer Healthcare. Anbesol® (benzocaine 20%) maximum strength gel drug facts. Madison, NJ; 2018.
118. Church and Dwight. Orajel® (benzocaine 20%, zinc chloride 0.1%, and benzylkonium chloride 0.02%) mouth sore gel drug facts. Ewing, NJ; 2018.
119. Church and Dwight. Orajel® (benzocaine 20%) maximum strength instant pain relief for mouth sores swabs drug facts. Ewing, NJ; 2018.
120. Church and Dwight. Orajel® (benzocaine 20%, menthol 0.5%, and zinc chloride 0.15%) severe toothache and gum relief plus triple medicated cream drug facts. Ewing, NJ; 2018.
121. Church and Dwight. Orajel® (benzocaine 20% and menthol 0.1%) severe toothache and gum relief plus double liquid drug facts. Ewing, NJ; 2018.
122. Church and Dwight. Orajel® (benzocaine 20%, menthol 0.7%, and zinc chloride 0.15%) for denture pain triple medicated gel. Ewing, NJ; 2018.
123. Boca Pharmacol. Antipyrine and benzocaine otic solution prescribing information. Coral Springs, FL; Jan 2011.
124. Prestige Consumer Healthcare. Chloroseptic® (benzocaine 15 mg) sore throat lozenges. Tarrytown, NY; 2018 Feb.
125. Sultan Healthcare. Topex® anesthetic metered spray (benzocaine 20%) prescribing information. York, PA; Dec 2017.
126. Prestige Consumer Healthcare. Chloroseptic® (benzocaine 6 mg, dextromethorphan hydrobromide 5 mg, and menthol 10 mg) sore throat and cough lozenges drug facts. Tarrytown, NY; 2017 May.
127. Cetylite. Cetacaine® (benzocaine 14% , butamben 2%, and tetracaine hydrochloride 2%) topical anesthetic liquid prescribing information. Pennsauken, NJ; 2016.
128. Cetylite. Cetacaine® (benzocaine 14% , butamben 2%, and tetracaine hydrochloride 2%) topical anesthetic gel prescribing information. Pennsauken, NJ; 2016.
129. Cetylite. Cetacaine® (benzocaine 14% , butamben 2%, and tetracaine hydrochloride 2%) topical anesthetic spray prescribing information. Pennsauken, NJ; 2016.
130. Beutilich. Hurricaine® (benzocaine 20%) topical anesthetic spray drug facts. Bunnell, FL; 2018 Jun.