Benzo-Jel
Benzo-Jel™ Unit Dose
Approved
Approval ID
e735d183-609e-53d6-6640-293356e0a8f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2018
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
PRODUCT DETAILS
NDC Product Code0404-0741
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJune 25, 2015
Generic NameBenzocaine
INGREDIENTS (5)
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
BenzocaineActive
Quantity: 200 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
D&c Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code0404-0743
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJune 25, 2015
Generic NameBenzocaine
INGREDIENTS (5)
BenzocaineActive
Quantity: 200 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
D&c Red No. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code0404-0742
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJune 25, 2015
Generic NameBenzocaine
INGREDIENTS (5)
BenzocaineActive
Quantity: 200 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Fd&c Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT