Drugplain

Dental City Topical Anesthetic 200 mg/g

Benzocaine · GEL · ICP Inc DBA Dental City

2 Recalls on Record
Plain English

Dental City Topical Anesthetic is a gel containing benzocaine at 200 mg/g, taken dental. Manufactured by ICP Inc DBA Dental City.

Key Facts

Brand Name
Dental City Topical Anesthetic
Generic Name
Benzocaine
NDC Code (Product)
69483-003
Manufacturer
ICP Inc DBA Dental City
Strength
200 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
04/01/2014

Recall History

2 Recalls on Record
Class II11/14/2024

Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

TerminatedVoluntary: Firm initiated
Class II05/21/2026

Keystone Industries

Defective container:may contain bottles with incomplete seals

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

methaemoglobinaemia124 reports
drug ineffective89 reports
drug hypersensitivity61 reports
off label use59 reports
asthenia48 reports
nausea47 reports
dyspnoea38 reports
arthralgia36 reports
anxiety35 reports
amnesia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use For oral mucosal use. Use only as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Dosage & Administration

Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use

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 immediate 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 Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age When using this product Avoid contact with eyes. If contact occurs, flush with water. Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast feeding, ask a phys

Frequently Asked Questions

What is Dental City Topical Anesthetic used for?

Dental City Topical Anesthetic contains Benzocaine. It is a gel taken dental. Consult your doctor for specific uses.

Is Dental City Topical Anesthetic a controlled substance?

Dental City Topical Anesthetic is not classified as a controlled substance by the DEA.

What is the generic name for Dental City Topical Anesthetic?

The generic name for Dental City Topical Anesthetic is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for Dental City Topical Anesthetic 200 mg/g?

The NDC (National Drug Code) for Dental City Topical Anesthetic 200 mg/g is 69483-003, listed by ICP Inc DBA Dental City.