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.

Gelato12gGrape

GELATO TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-502
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine2.4 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
May containFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
May containFD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
May containFD&C RED NO. 40 (UNII: WZB9127XOA)  
May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
May containFD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-502-2512 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(68400-502) , label(68400-502)

Revised: 11/2013
Document Id: f960829d-5c3d-4448-a0be-c0b2f9289d5a
Set id: 5991bbb4-754f-489e-9708-1ca1b6a4280f
Version: 2
Effective Time: 20131119
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.