GELATO TOPICAL ANESTHETIC- benzocaine spray, metered 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

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:

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

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.

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

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GELATO TOPICAL ANESTHETIC 
benzocaine spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-323
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.4 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ALCOHOL (UNII: 3K9958V90M)  
ISOBUTANE (UNII: BXR49TP611)  
PROPANE (UNII: T75W9911L6)  
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-323-3557 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (014769301)
Establishment
NameAddressID/FEIBusiness Operations
Keystone Industries014769301manufacture(68400-323) , label(68400-323)

Revised: 1/2022
Document Id: d619937b-4c82-e940-e053-2a95a90a08fa
Set id: 9991de96-99a1-42f0-9ddd-e530ca9ceab1
Version: 6
Effective Time: 20220121
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc