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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
Endoscopic procedure - Pain; Prophylaxis
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
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Non–Guideline-Supported Use
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
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
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Non–Guideline-Supported Use
Contraindications
There is limited information regarding Benzocaine (injection) Contraindications in the drug label.
Warnings
Allergy alert
When using this product
Stop use and ask a doctor if
Adverse Reactions
Clinical Trials Experience
Postmarketing Experience
Drug Interactions
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Pregnancy Category (AUS):
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
Monitoring
IV Compatibility
Overdosage
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
Anbesol Jr. Gel
Precautions with Alcohol
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.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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