GELATO TOPICAL ANESTHETIC GEL BENZOCAINE PINA COLADA 1 OZ - 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 Blue 1
  • FDC Red 40
  • FDC Yellow 5 (tartrazine) as a color additive
  • FDC Yellow 6
  • 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 GEL BENZOCAINE PINA COLADA 1 OZ 
benzocaine topical anesthetic gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-309
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine ) Benzocaine6 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 
Polyethylene Glycol 3350 
Saccharin Sodium 
Product Characteristics
Color    Score    
ShapeSize
FlavorPINEAPPLE (Pina Colada) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-309-3030 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/12/2012
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(68400-309), label(68400-309)

Revised: 12/2012
Document Id: e21b1cc7-c81c-4b8d-b501-5b63c93ef9d5
Set id: 9e6f426b-192a-4104-a0a8-c3378ced5710
Version: 1
Effective Time: 20121212
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.