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Gelato Topical Anesthetic Gel

Generic name: benzocaine
Dosage form: dental gel
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.

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)
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.