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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68400-504
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateNovember 19, 2013
FDA Product Classification
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