GELATO TOPICAL ANESTHETIC- benzocaine spray, metered

Gelato Topical Anesthetic by

Drug Labeling and Warnings

Gelato Topical Anesthetic by is a Otc medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc, Keystone Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

• For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
• For Professional Use Only.

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.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Do not use

• for teething
• in children under 2 years of age

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Avoid spraying in eyes.

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 room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Inactive Ingredients

Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane).

Questions or comments?

1-800-333-3131

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELATO TOPICAL ANESTHETIC 
benzocaine spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68400-323
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	11.4 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-323-35	57 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/29/2013

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)

Establishment
Name	Address	ID/FEI	Business Operations
Keystone Industries		014769301	manufacture(68400-323) , label(68400-323)