Ztlido
These highlights do not include all the information needed to use ZTLIDO safely and effectively. See full prescribing information for ZTLIDO. ZTLIDO (lidocaine topical system) Initial U.S. Approval: 1953
Approved
Approval ID
a1b17507-4560-490d-a388-74e7fd7eaa5e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2021
Manufacturers
FDA
Scilex Pharmaceuticals Inc.
DUNS: 078286225
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69557-111
Application NumberNDA207962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 21, 2021
FDA Product Classification
INGREDIENTS (8)
LIDOCAINEActive
Quantity: 36 mg in 1 1
Code: 98PI200987
Classification: ACTIB
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT
ISOSTEARIC ACIDInactive
Code: X33R8U0062
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT