Topical Anesthetic
Topical Anesthetic Gel - 20% Benzocaine
Approved
Approval ID
9bc3dbbb-b54f-42d2-a019-a1bf6294ccbe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 4, 2018
Manufacturers
FDA
NDC, Inc.
DUNS: 009831413
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
PRODUCT DETAILS
NDC Product Code43128-023
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
Generic NameBenzocaine
INGREDIENTS (6)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
BenzocaineActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
D&C GREEN NO. 5Inactive
Code: 8J6RDU8L9X
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code43128-020
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
Generic NameBenzocaine
INGREDIENTS (6)
BenzocaineActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code43128-024
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
Generic NameBenzocaine
INGREDIENTS (5)
BenzocaineActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code43128-026
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
Generic NameBenzocaine
INGREDIENTS (6)
BenzocaineActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code43128-022
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
Generic NameBenzocaine
INGREDIENTS (6)
BenzocaineActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
Benzocaine
PRODUCT DETAILS
NDC Product Code43128-021
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
Generic NameBenzocaine
INGREDIENTS (6)
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
BenzocaineActive
Quantity: 220 mg in 1 g
Code: U3RSY48JW5
Classification: ACTIB
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TY
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT