Drugplain

Avant 6.4 g/100g

Benzocaine · GEL · Dharma Research, Inc.

2 Recalls on Record
Plain English

Avant is a gel containing benzocaine at 6.4 g/100g, taken dental. Manufactured by Dharma Research, Inc..

Key Facts

Brand Name
Avant
Generic Name
Benzocaine
NDC Code (Product)
53045-147
Manufacturer
Dharma Research, Inc.
Strength
6.4 g/100g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
01/22/2021

Recall History

2 Recalls on Record
Class II07/15/2022

Aire-Master of America Inc

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

TerminatedVoluntary: Firm initiated
Class II07/15/2022

Aire-Master of America Inc

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents5,906 reports
completed suicide5,397 reports
drug abuse5,226 reports
overdose1,890 reports
death1,643 reports
intentional overdose1,529 reports
cardio-respiratory arrest1,343 reports
suicide attempt1,333 reports
somnolence923 reports
drug dependence903 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of pain associated with canker sores and minor dental procedures.

Dosage & Administration

Directions Adults and children 2 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a dentist or doctor.

Warnings

Warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy Alergy 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. Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly. Do not exceed recommended dosage.

Frequently Asked Questions

What is Avant used for?

Avant contains Benzocaine. It is a gel taken dental. Consult your doctor for specific uses.

Is Avant a controlled substance?

Avant is not classified as a controlled substance by the DEA.

What is the generic name for Avant?

The generic name for Avant is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for Avant 6.4 g/100g?

The NDC (National Drug Code) for Avant 6.4 g/100g is 53045-147, listed by Dharma Research, Inc..

Product NDC

53045-147

Package NDC

53045-147-30

Other Benzocaine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)