Benzocaine (injection)

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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.

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

### 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.

### NonGuideline-Supported Use
- There is limited information regarding Off-Label NonGuideline-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

## Package and Label Display Panel

# 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