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

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IFU available upon request.

Gelato12gMint

GELATO TOPICAL ANESTHETIC 
benzocaine topical anesthetic gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-503
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine ) Benzocaine2.4 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 
Polyethylene Glycol 3350 
Saccharin Sodium 
Other Ingredients
Ingredient KindIngredient NameQuantity
May containFD&C YELLOW NO. 5 
May containFD&C YELLOW NO. 6 
May containFD&C RED NO. 3 
May containFD&C RED NO. 40 
May containFD&C BLUE NO. 1 
May containFD&C GREEN NO. 3 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-503-2512 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
export only12/12/2012
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)
Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
Establishment
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.078654194manufacture(68400-503), label(68400-503)

Revised: 11/2013
Document Id: b8e964da-ef7b-4230-878c-eb2820d45238
Set id: 1be6cd7a-3f9c-4661-85e4-4a310b490ad3
Version: 2
Effective Time: 20131119
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.