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Gelato Topical Anesthetic Gel

Generic Name: benzocaine
Dosage Form: dental gel

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.

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 Yellow 5 (tartrazine) as a color additive
  • Flavor
  • PEG 400
  • PEG 3350
  • Sodium Saccharin
  • Store at controlled room temperature 59-86 F (15-30 C)
  • Protect from freezing and heat

GELATO TOPICAL ANESTHETIC 
benzocaine gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-316
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 6 g  in 30 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol 400  
Polyethylene Glycol 3350  
Saccharin Sodium  
Product Characteristics
Color      Score     
Shape Size
Flavor BANANA Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68400-316-30 30 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/12/2012 03/31/2015
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
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture(68400-316), label(68400-316)
Revised: 08/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.



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