DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%
DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%
Approved
Approval ID
888a969b-95dd-296c-e053-2995a90afa24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2019
Manufacturers
FDA
Sincerus Florida, LLC
DUNS: 080105003
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72934-5071
Product Classification
G
Generic Name
DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 10, 2019
FDA Product Classification
INGREDIENTS (4)
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 1 g in 100 g
Code: 04JA59TNSJ
Classification: ACTIB
DIBUCAINE HYDROCHLORIDEActive
Quantity: 0.5 g in 100 g
Code: Z97702A5DG
Classification: ACTIB
LIDOCAINEActive
Quantity: 15 g in 100 g
Code: 98PI200987
Classification: ACTIB
PRILOCAINEActive
Quantity: 5 g in 100 g
Code: 046O35D44R
Classification: ACTIB