Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g

Benzocaine · GEL · Safco Dental Supply Co.

1 Recall on Record

Plain English

Sensicaine Ultra is a topical anesthetic gel containing benzocaine that is applied to the gums and mouth to numb pain and discomfort before dental procedures or for minor mouth irritation. This over-the-counter product works by blocking nerve signals in the area where it is applied.

Key Facts

Brand Name: Safco Sensicaine Ultra Topical Anesthetic Gel
Generic Name: Benzocaine
NDC Code (Product): 67239-0223
Manufacturer: Safco Dental Supply Co.
Strength: 200 mg/g
Dosage Form: GEL
Route: DENTAL
Marketing Status
Application #: M022
Drug Class: Standardized Chemical Allergen [EPC]
Marketing Start: 03/05/2019

Recall History

1 Recall 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

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 Safco Sensicaine Ultra Topical Anesthetic Gel used for?

Is Safco Sensicaine Ultra Topical Anesthetic Gel a controlled substance?

Safco Sensicaine Ultra Topical Anesthetic Gel is not classified as a controlled substance by the DEA.

What is the generic name for Safco Sensicaine Ultra Topical Anesthetic Gel?

The generic name for Safco Sensicaine Ultra Topical Anesthetic Gel is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g?

The NDC (National Drug Code) for Safco Sensicaine Ultra Topical Anesthetic Gel 200 mg/g is 67239-0223, listed by Safco Dental Supply Co..

Product NDC

67239-0223

Package NDC

67239-0223-1

Other Benzocaine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)