GELATO TOPICAL ANESTHETIC GEL BENZOCAINE MINT 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.
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 Green 3
- FDC Yellow 5 (tartrazine) as a color additive
- 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 GEL BENZOCAINE MINT 1 OZ |
benzocaine topical anesthetic gel
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:68400-307 |
|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 ||MINT ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:68400-307-30 ||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.
|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 (68400-307), label (68400-307) |
Revised: 12/2012 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.