GingiCaine Gel, Mint Julep Flabvor

FDA Drug Profile — GingiCaine Gel, Mint Julep

GingiCaine Gel, Mint Julep Flabvor is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including GingiCaine Gel, Mint Julep. Available dosage form: gel.

Drug Details

Generic Name
GingiCaine Gel, Mint Julep Flabvor
Brand Names
GingiCaine Gel, Mint Julep
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

Uses For anesthesia of mucous membrane of oropharynx. Temporary relief of pain or discomfort caused by • Minor dental procedures • Minor gum injury • canker sores • Sore throat • Minor mouth or gum irritations caused by dentures or orthodontic appliances

Warnings

Warnings Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age. For topical use only Methemoglobinemia warning 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 Stop use and ask a doctor if (signs of toxicity) • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting develops • Mouth sores do not go away in 7 days • Irritation, pain, or redness worsens