Gelato Topical Anesthetic
Gelato Topical Anesthetic is an FDA drug label for the active ingredient BENZOCAINE manufactured by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231207.
Generic: BENZOCAINE
Manufacturer: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Product Type: HUMAN OTC DRUG
Route: DENTAL
Dosage Form:
NDC: 68400-350
Application: M022
Effective: 20231207
Active Ingredients: Active Ingredients Benzocaine 200mg (in each g)
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
Contraindications
Not available.
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 physician before use.
Adverse Reactions
Not available.