Gelato Topical Anesthetic Gel Benzocaine Bubble Gum 1 Oz

GELATO TOPICAL ANESTHETIC GEL BENZOCAINE BUBBLE GUM 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.

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

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

Each gram of 20 percent benzocaine gel has 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
(click image for full-size original)

GELATO TOPICAL ANESTHETIC GEL BENZOCAINE BUBBLE GUM 1 OZ
benzocaine topical anesthetic gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-308
Route of Administration DENTAL, TOPICAL, ORAL 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 BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68400-308-30 30 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/12/2012
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
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture (68400-308), label (68400-308)

Revised: 12/2012 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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