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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-0741
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 25, 2015
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-0743
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 25, 2015
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-0742
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 25, 2015
FDA Product Classification
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