GingiCaine Gel, Cotton Candy Flavor

FDA Drug Profile — GingiCaine Gel, Cotton Candy Flavor

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

Drug Details

Generic Name
GingiCaine Gel, Cotton Candy Flavor
Brand Names
GingiCaine Gel, Cotton Candy Flavor
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 Uses For the temporary relief of pain due to: • Minor irritation or injury of oral mucous membrane • Minor dental procedures • Minor irritation of mouth or gums caused by dentures or orthodontic appliances

Warnings

Warnings For topical use only. 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. Symptoms may occur within minutes to 1–2 hours after use and include: • Pale, gray, or blue‑colored skin, lips, and nail beds • Shortness of breath • Fatigue or lack of energy Stop use and ask a doctor if: • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting occur • Mouth does not heal within 7 days • Irritation, pain, or redness worsens