Topical Anesthetic
Topical Anesthetic Banana Flavor Gel
Approved
Approval ID
f4fdfcaf-aa95-45a8-ba91-7a8716f6f3d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 13, 2010
Manufacturers
FDA
Patterson Dental
DUNS: 171843584
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 Code50227-2116
Application Numberpart356
Product Classification
M
Marketing Category
C73604
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationDENTAL
Effective DateMay 13, 2010
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
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT