Benzocaine (topical)

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Benzocaine (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Benzocaine (topical) is a local anesthetic that is FDA approved for the treatment of dental pain. Common adverse reactions include contact dermatitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • For oral mucosal use only as directed by a dentist.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzocaine (topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzocaine (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Benzocaine (topical) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzocaine (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzocaine (topical) in pediatric patients.

Contraindications

There is limited information regarding Benzocaine (topical) Contraindications in the drug label.

Warnings

There is limited information regarding Benzocaine (topical) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Benzocaine (topical) in the drug label.

Postmarketing Experience

contact dermatitis, methemoglobinemia (rare)

Drug Interactions

There is limited information regarding Benzocaine (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzocaine (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Benzocaine (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Benzocaine (topical) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Benzocaine (topical) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Benzocaine (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benzocaine (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benzocaine (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benzocaine (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benzocaine (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benzocaine (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benzocaine (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Benzocaine (topical) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Benzocaine (topical) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Benzocaine (topical) in the drug label.

Pharmacology

Benzocaine.png
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Benzocaine (topical)
Systematic (IUPAC) name
Ethyl 4-aminobenzoate
Identifiers
CAS number 94-09-7
ATC code C05AD03 D04AB04 (WHO), Template:ATCvet, N01BA05 (WHO), R02AD01 (WHO)
PubChem 2337
DrugBank DB01086
Chemical data
Formula C9H11NO2 
Mol. mass 165.189 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

C(US)

Legal status

OTC(US)

Routes Topical

Mechanism of Action

There is limited information regarding Benzocaine (topical) Mechanism of Action in the drug label.

Structure

There is limited information regarding Benzocaine (topical) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benzocaine (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Benzocaine (topical) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Benzocaine (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Benzocaine (topical) in the drug label.

How Supplied

There is limited information regarding Benzocaine (topical) How Supplied in the drug label.

Storage

  • Store at controlled room temperature 59-86°F (15-30°C).

Images

Drug Images

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Benzocaine (topical) in the drug label.

Precautions with Alcohol

  • Alcohol-Benzocaine (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • TOPICAL ANESTHETIC BANANA®[1]

Look-Alike Drug Names

There is limited information regarding Benzocaine (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "TOPICAL ANESTHETIC BANANA- benzocaine gel, dentifrice".

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