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Benzocaine topical

Pronunciation

Class: Antipruritics and Local Anesthetics
VA Class: NT300
CAS Number: 94-09-7
Brands: Americaine, Anacaine, Chiggerex, Chiggertox, Dermoplast, Foille, Ivarest, Outgro, Solarcaine

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

Uses for Benzocaine

Dermatologic Conditions

Self-medication for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts or scrapes, insect bites, or minor skin irritations.e h i j

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Usually used in fixed-combination with an antibacterial (e.g., benzethonium chloride), antipruritic (e.g., menthol), or skin protectant (e.g., calamine).h i j

Hemorrhoids

Self-medication for temporary relief of pain and itching associated with hemorrhoids.c

Premature Ejaculation

Self-medication, as a male genital desensitizer, to aid in slowing the onset of ejaculation.b

Anesthetic Lubricant

For topical anesthesia and lubricant on intratracheal catheters and pharyngeal and nasal airways to obtund pharyngeal and tracheal reflexes and on nasogastric and endoscopic tubes, urinary catheters, laryngoscopes, proctoscopes, sigmoidoscopes, and vaginal specula.d

Benzocaine Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as an aerosol spray, cream, gel, lotion, ointment, or solution.a

Avoid contact with the eye(s) and do not apply to e deep or puncture wounds or to serious burns.a

Aerosol Spray

Shake well prior to use.h

Hold spray canister approximately 6–12 inches away from the affected area.h

To avoid contact with eyes when applying to face, first spray the drug into the palm of hand and then apply.h

Dosage

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.

Dermatologic Conditions
Topical

Children ≥2 years of age (Self-medication): Apply 5–20% aerosol spray, cream, lotion, ointment, or solution 3 or 4 times daily or as directed by a clinician.e

Anesthetic Lubricant
Topical

Children ≥1 year of age: Apply 20% gel to the exterior of the tube or instrument prior to use.d

Hemorrhoids
Topical

Children ≥12 years of age (self-medication): Apply 20% ointment to cleansed, affected area up to 6 times daily.c

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.

Dermatologic Conditions
Topical

Self-medication for the temporary relief of pain and itching associated with various skin conditions, apply 5–20% aerosol spray, cream, lotion, ointment, or solutions 3 or 4 times daily or as directed by a clinician.e

Hemorrhoids
Topical

Self-medication for the temporary relief of pain and itching associated with hemorrhoids, apply 20% ointment to cleansed, affected area up to 6 times daily.c

Premature Ejaculation
Topical

Self-medication to aid in slowing the onset of ejaculation, apply a small amount of a preparation containing 3–7.5% benzocaine in a water-soluble base to the head and shaft of the penis before intercourse.b

After intercourse, wash off any remaining benzocaine to minimize the chance of an allergic reaction occurring.b

Anesthetic Lubricant
Topical

For topical anesthesia and lubrication during instrumentation (see Anesthetic Lubricant under Uses), apply 20% water-soluble gel to the exterior of the tube or instrument prior to use.d

Cautions for Benzocaine

Contraindications

  • Known hypersensitivity to benzocaine, other ester-type local anesthetics, or any ingredient in the formulation.a

Warnings/Precautions

Warnings

Administration

For external use only.a

Avoid contact with the eyes.a e

Not intended for prolonged use (e.g., >1 week).a i

When used for self-medication, discontinue the drug and consult a clinician if the condition worsens or symptoms persist for >7 days or clear and occur again within a few days, if infection or bleedingc occurs, or if rash or irritation occurs.a b

When used for genital desensitization, recognize that premature ejaculation may be due to a condition requiring medical attention.b

Sensitivity Reactions

Possible sensitization.a d

If a rash or irritation develops during therapy, discontinue the drug and consult a clinician.a d

When used for self-medication as a male genital desensitizer, advise the male to use the drug with caution if his sexual partner is sensitive to local anesthetics, sunscreens, sulfa drugs, or hair dyes.a Discontinue therapy if rash or irritation (e.g., burning, itching) occurs; consult clinician if symptoms persists.b

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.

Possible methemoglobinemia; closely adhere to dosing recommendations.g

Serious Adverse Effects associated with Local Anesthetics

Risk of serious adverse effects (e.g., seizures, coma, irregular heart beat, respiratory depression) with use of topical local anesthetics; generally reported following application of extemporaneously prepared topical preparations containing high concentrations of anesthetics.k

Potential for life-threatening adverse effects (e.g., irregular heart beat, seizures, breathing difficulties, coma, death) when topical local anesthetics are applied to a large area of skin, when the area of application is covered with an occlusive dressing, if a large amount of topical anesthetic is applied, if the anesthetic is applied to irritated or broken skin, or if the skin temperature increases (from exercise or use of a heating pad).101 102

Lidocaine 4% gel has been investigated to reduce discomfort during mammography.101 103 Whether such use could result in serious reactions has not been determined.101 103 Patients should speak with their clinician if they are considering using a topical anesthetic before obtaining a mammogram.101

When a topical anesthetic is needed for a procedure, use of an FDA-approved preparation has been recommended.k Use a preparation containing the lowest concentration of anesthetic likely to be effective; apply a small amount of the preparation to the affected area for the shortest period necessary for the desired effect,k and do not apply to broken or irritated skin.101 fn

Specific Populations

Pregnancy

Category C.d

Lactation

Not known whether benzocaine is distributed into milk; use with caution.d

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 aerosol spray, cream, lotion, ointment, or solution not established in children <2 years of age;e use only under the direction of a clinician.a

Safety and efficacy of 20% gel not established in children <1 year of age.d

Common Adverse Effects

Generally nontoxic when applied topically, but sensitization can occur.a Contact dermatitis and/or hypersensitivity can result in burning, stinging, pruritus, tenderness, erythema, rash, urticaria, and edema.d

Male genital desensitization preparations usually do not adversely affect female orgasm in the sexual partner, but sensitization can occur.a (See Sensitivity Reactions under Cautions.)

Stability

Storage

Topical

Aerosol

<40°C, preferably between 15–30°C.a

Do not puncture, use, or store aerosol containers near heat or an open flame, expose to temperatures >49°C, or place into a fire or incinerator for disposal.a

Creams

Tight, light-resistant containers at <40°C, preferably between 15–30°C.a Avoid prolonged exposure to temperatures >30°C.a

Gels

15–25°C.d

Ointments

Tight, light-resistant containers at <40°C, preferably between 15–30°C.a Avoid prolonged exposure to temperatures >30°C.a

Solutions

<40°C, preferably 15–30°C.a Do not freeze.a

Actions

  • Blocks the initiation and conduction of nerve impulses by inhibiting the depolarization of the neuronal membrane.d

  • Structurally similar to procaine.g (See Methemoglobinemia under Cautions.)

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.

  • Risk of sensitization.a Importance of discontinuing therapy and consulting clinician if a rash or irritation develops during therapy.a

  • Importance of avoiding contact with the eyes.a e

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

  • When a topical anesthetic is used for a procedure, importance of applying the preparation as directed by a clinician.k

  • Importance of discontinuing therapy and consulting clinician if dermatologic condition worsens or symptoms persist for >7 days or clear and occur again within a few days, if infection or bleedingc occurs, or if rash or irritation occurs.a b e

  • Advise patients using benzocaine for genital desensitization that premature ejaculation may be due to a condition requiring medical attention.b Discontinue and consult a clinician if relief is not obtained following use as directed or if the patient or their sexual partner develops a rash or irritation.b

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

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

  • Importance of informing patients of other important precautionary information.d (See Contraindications and also see Warnings/Precautions under Cautions.)

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Benzocaine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Aerosol

5%

Foille Medicated First Aid

Blistex

20%

Americaine First Aid Spray

Insight

Dermoplast

MedTech

Solarcaine

Schering-Plough

Cream

5%*

Benzocaine Cream

Ivarest

Blistex

Gel

20%

Americaine Anesthetic Lubricant

Celltech

Lotion

0.5%

Solarcaine

Schering-Plough

5%

Ointment

2%

Chiggerex

Scherer

5%

Foille Medicated First Aid

Blistex

10%

Anacaine

Gordon

20%

Americaine Hemorrhoidal Ointment

Insight

Solution

2.1%

Chiggertox

Scherer

20%

Outgro

MedTech

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

a. AHFS drug information 2004. McEvoy GK, ed. Benzocaine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:3411.

b. Food and Drug Administration. Male genital desensitizing drug products for over the counter human use. 21 CFR Part 348. From the FDA website: (. Revised 2003 Apr.

c. Insight Pharmaceuticals. Americaine (benzocaine 20%) hemorrhoidal ointment prescribing information. From the Insight website: (. Accessed 2004 Jan 23.

d. Celltech pharmaceuticals, Inc. Americaine (benzocaine) anesthetic lubricant prescribing information. Rochester, NY; 2001 Jul.

e. Food and Drug Administration. External analgesic drug products for over-the-counter human use; tentative final monograph. 21 CFR Part 348. Fed Regist. 1983; 48:5867-9.

g. Catterall W, Mackie K. Local anesthetics. In: Gilman AG, Goodman LS, Rall TW et al eds. Goodman and Gilman’s the pharmacologic basis of therapeutics. 10th ed. New York: Macmillan Publishing Company. 2001:376.

h. Medtech. Dermoplast (benzocaine) hospital strength pain relieving spray prescribing information. In: Physician’s desk reference for nonprescription drugs and dietary supplements. 23rd. ed. Montvale, NJ; Medical Economics Company, Inc.; 2002:689.

i. Medtech. Dermoplast (benzocaine) antibacterial spray prescribing information. In: Physician’s desk reference for nonprescription drugs and dietary supplements. 23rd. ed. Montvale, NJ; Medical Economics Company, Inc.; 2002:689-70.

j. Blistex. Ivarest medicated cream & lotion prescribing information. In: Physician’s desk reference for nonprescription drugs. 8th. ed. Montvale, NJ; Medical Economics Company, Inc.; 1987:521.

k. 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 ().

101. Food and Drug Administration. FDA Public Health Advisory: Potential hazards of skin products containing numbing ingredients for relieving pain from mammography and other medical tests and conditions. 2009 Jan 16. From FDA website ().

102. Food and Drug Administration. Topical Anesthetics. MedWatch alert. Rockville, MD; 2009 Jan 16. From FDA website (

103. Lambertz CK, Johnson CJ, Montgomery PG et al. Premedication to reduce discomfort during screening mammography. Radiology. 2008; 248:765-72. [PubMed 18647845]

fn. Other references apply.

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