Patterson Dental Topical Anesthetic

Benzocaine · Gel · Dental

Over the counter Standardized Chemical Allergen 1 recall

Active ingredient

Benzocaine 200mg (in each g)

Purpose

Oral Anesthetic

Uses

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

Warnings

Methemoglobinemia warning : Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of o 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 physician before use.

Keep out of reach of children

Keep out of reach of children.

Directions

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

Other information

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions?

800.873.7683

Label text from the FDA structured product label by Patterson Dental (revised Sep 18, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Patterson Dental Topical Anesthetic NDC products (12)

NDCStrength & formLabelerType
50227-1001Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1002Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1003Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1004Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1005Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1007Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1009Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1010Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1011Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1012Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1013Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG
50227-1014Benzocaine 200 mg/g
Gel		Patterson DentalOTC MONOGRAPH DRUG

Patterson Dental Topical Anesthetic recalls

Frequently asked questions

What is Patterson Dental Topical Anesthetic used for?

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

Who makes Patterson Dental Topical Anesthetic?

Patterson Dental Topical Anesthetic is listed by 1 labeler in the FDA NDC directory, including Patterson Dental.

Has Patterson Dental Topical Anesthetic been recalled?

The FDA enforcement database lists 1 recall for Patterson Dental Topical Anesthetic, most recently D-0141-2025 (class ii): 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…