Gingicaine Gel Strawberry Flavor

FDA Drug Profile — Gingicaine Gel Strawberry

Gingicaine Gel Strawberry Flavor is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Gingicaine Gel Strawberry. Available dosage form: gel.

Drug Details

Generic Name
Gingicaine Gel Strawberry Flavor
Brand Names
Gingicaine Gel Strawberry
Application Number
M022
Sponsor
Gingi-Pak a Division of the Belport
NDC Codes
1
Dosage Forms
GEL
Routes
DENTAL, ORAL, PERIODONTAL
Active Ingredients
BENZOCAINE

Indications and Usage

Indications and usage section For anesthesia of mucous membrane of oropharynx. Temporarily relieves pain or discomfort caused by minor dental procedures, orthodontic appliances, teething, canker sores, cold sores, fever blisters, minor injury of the mouth or gums, and irritations caused by dentures or orthodontic appliances.

Warnings

Precaution Section Dentists should avoid application to severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes. Local anesthetics should be used with caution in patients with known drug sensitivities, particularly those known to be allergic to ester-type anesthetics (procaine, benzocaine, tetracaine). Dentists should avoid contact with all local anesthetics to avoid possible sensitization. Warnings For topical use only. Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop: • Pale, gray, or blue colored skin (cyanosis) • Headache • Rapid heart rate • Shortness of breath • Dizziness or lightheadedness • Fatigue or lack of energy Do not use in children under 2 years of age.