Drugplain

Pearson Topical Anesthetic 200 mg/g

Benzocaine · GEL · Pearson Dental Supplies INC.

No Recall History
Plain English

Pearson Topical Anesthetic is an over-the-counter gel containing benzocaine that you apply directly to the gums and mouth to numb pain from dental procedures, sores, or other oral discomfort. Benzocaine works by blocking nerve signals in the area where it's applied, providing temporary local anesthesia.

Key Facts

Brand Name
Pearson Topical Anesthetic
Generic Name
Benzocaine
NDC Code (Product)
43305-0001
Manufacturer
Pearson Dental Supplies INC.
Strength
200 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
07/01/2013

Recall History

No Recall History

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 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 Pearson Topical Anesthetic used for?

Pearson Topical Anesthetic is an over-the-counter gel containing benzocaine that you apply directly to the gums and mouth to numb pain from dental procedures, sores, or other oral discomfort. Benzocaine works by blocking nerve signals in the area where it's applied, providing temporary local anesthesia.

Is Pearson Topical Anesthetic a controlled substance?

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

What is the generic name for Pearson Topical Anesthetic?

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

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

The NDC (National Drug Code) for Pearson Topical Anesthetic 200 mg/g is 43305-0001, listed by Pearson Dental Supplies INC..

Product NDC

43305-0001

Package NDC

43305-0001-3

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)