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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43128-023
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43128-020
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43128-024
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43128-026
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43128-022
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43128-021
Product Classification
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 4, 2018
FDA Product Classification
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