Gelato Topical Anesthetic
Approved
Approval ID
2f764009-5405-4ff5-8223-12d2aedeb2ad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2013
Manufacturers
FDA
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
DUNS: 078654194
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
PRODUCT DETAILS
NDC Product Code68400-504
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateNovember 19, 2013
Generic NameBenzocaine
INGREDIENTS (10)
BenzocaineActive
Quantity: 2.4 g in 12 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: CNTM
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: CNTM
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: CNTM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: CNTM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: CNTM
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: CNTM