Benzocaine (injection)

Benzocaine (injection)
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: Deepika Beereddy, MBBS [2]

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Overview

Benzocaine (injection) is a local anesthetic that is FDA approved for the treatment of disorder of dental prosthesis - pain due to any device, implant and/or graft prophylaxis of endoscopic procedure - pain; insertion of nasogastric tube -pain, otitis - topical local anesthetic, skin irritation - topical local anesthetic, stomatitis - topical local anesthetic, toothache, topical local anesthetic, for general use during catheterization and/or diagnostic and surgical procedures, topical local anesthetic - ulcer of mouth. Common adverse reactions include contact dermatitis, disorder of taste.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft

• Dosing Information

• Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft: (10% oral rinse) swish and spit 15 mL; repeat after 1 h and up to 4 times daily
• Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft: (6% oral strips) dissolve one strip on irritated area up to 4 times daily
• Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft: (oral gel) apply thin layer of oral gel TOPICALLY to the affected areas up to 4 times daily, do not reinsert dental work until irritation/pain is relieved; rinse mouth well before reinserting dentures

Endoscopic procedure - Pain; Prophylaxis

• Dosing Information

• Endoscopic procedure - Pain; Prophylaxis: (20% anesthetic lubricant) apply evenly to exterior of tube or instrument prior to use

Insertion of nasogastric tube - Pain

• Dosing Information

• Insertion of nasogastric tube - Pain: (20% anesthetic lubricant) apply evenly to exterior of tube or instrument prior to use

Otitis - Topical local anesthetic

• Dosing Information

• Otitis - Topical local anesthetic: instill 4 to 5 drops of otic solution into external ear canal of affected ear(s), repeat every 1 to 2 h if necessary

Skin irritation - Topical local anesthetic

• Dosing Information

• Skin irritation - Topical local anesthetic: apply TOPICALLY to affected area not more than 3 to 4 times daily holding can 6 to 12 inches away from affected area

Stomatitis - Topical local anesthetic

• Dosing Information

• Stomatitis - Topical local anesthetic: apply TOPICALLY to affected areas up to 4 times daily

Toothache

• Dosing Information

• Toothache: apply gel, liquid, or ointment TOPICALLY to affected areas up to 4 times daily

Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures

• Dosing Information

• Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures: (20% anesthetic lubricant) apply evenly to exterior of tube or instrument prior to use

Topical local anesthetic - Ulcer of mouth

• Dosing Information

• Topical local anesthetic - Ulcer of mouth: apply TOPICALLY to affected areas up to 4 times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft

Endoscopic procedure - Pain; Prophylaxis

• Dosing Information

• Endoscopic procedure - Pain; Prophylaxis: (ages 1 year and older) 20% anesthetic lubricant, apply evenly to exterior of tube or instrument prior to use

Insertion of nasogastric tube - Pain

• Dosing Information

• Insertion of nasogastric tube - Pain: (ages 1 year and older) 20% anesthetic lubricant, apply evenly to exterior of tube or instrument prior to use

Otitis - Topical local anesthetic

• Dosing Information

• Otitis - Topical local anesthetic: (age 1 y and older) instill 4 to 5 drops of otic solution into external ear canal of affected ear(s), repeat every 1 to 2 h if necessary

Skin irritation - Topical local anesthetic

• Dosing Information

• Skin irritation - Topical local anesthetic: (ages 2 years and older) apply TOPICALLY to affected area not more than 3 to 4 times daily holding can 6 to 12 inches away from affected area

Stomatitis - Topical local anesthetic

• Dosing Information

• Stomatitis - Topical local anesthetic: (ages 2 years and older) apply TOPICALLY to affected areas up to 4 times daily

Toothache

• Dosing Information

• Toothache: (2 years and older) apply gel, liquid, or ointment to affected areas up to 4 times daily

Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures

• Dosing Information

• Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures: (ages 1 year and older) 20% anesthetic lubricant, apply evenly to exterior of tube or instrument prior to use

Topical local anesthetic - Ulcer of mouth

• Dosing Information

• Topical local anesthetic - Ulcer of mouth: (ages 2 years and older) apply TOPICALLY to affected areas up to 4 times daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

Allergy alert

• Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

When using this product

• avoid contact with the eyes
• do not exceed recommended dosage
• do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling, rash, or fever develops

• Keep out of reach of children.

• If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Benzocaine (injection) in the drug label.

Drug Interactions

• Drug

• Description

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 (injection) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

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

Pharmacology

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

There is limited information regarding Benzocaine (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Anbesol Regular and Maximum Strength Liquid

• adults and children 2 years of age and older:

• wipe liquid on with cotton, or cotton swab, or fingertip
• apply to the affected area up to 4 times daily or as directed by a doctor/dentist

• children under 12 years of age: adult supervision should be given in the use of this product
• children under 2 years of age: consult a doctor/dentist

• Anbesol Regular and Maximum Strength Gel

• to open tube, cut tip of the tube on score mark with scissors
• adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentist
• children under 12 years of age: adult supervision should be given in the use of this product
• children under 2 years of age: consult a doctor/dentist
• for denture irritation:

• apply thin layer to the affected area
• do not reinsert dental work until irritation/pain is relieved
• rinse mouth well before reinserting

Anbesol Jr. Gel

• to open tube, cut tip of the tube on score mark with scissors
• adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentist
• children under 12 years of age: adult supervision should be given in the use of this product
• children under 2 years of age: consult a doctor/dentist

Precautions with Alcohol

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

Brand Names

Orajel, Americaine, Anacaine, Anbesol, Benzodent, Bi-Zets/Benzo-Troches, Chiggerex, Dent's.

Look-Alike Drug Names

There is limited information regarding Benzocaine (injection) 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.

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