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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DIRECTIONS: For oral mucosa. Use only as directed by a dentist.

CAUTION: Keep out of reach of children. For professional use only.

Each gram of 20 percent benzocaine gel contains 200mg of benzocaine in a water soluble base of:

  • FDC Red 40
  • Flavor
  • PEG 400
  • PEG 3350
  • Sodium Saccharin

  • Store at controlled room temperature 59-86 F (15-30 C)
  • Protect from freezing and heat

Label
GELATO TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-305
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine6 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-305-3030 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/12/201203/31/2016
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(68400-305) , label(68400-305)

Revised: 8/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.