Lidothol
Lidothol Gel
Approved
Approval ID
db7795f5-7131-4814-9ad7-3b5c583b6432
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LIDOCAINE HCl, MENTHOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68788-8129
Product Classification
G
Generic Name
LIDOCAINE HCl, MENTHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (15)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMInactive
Code: DE08037SAB
Classification: IACT
ILEX PARAGUARIENSIS LEAFInactive
Code: 1Q953B4O4F
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
MENTHOL, UNSPECIFIED FORMActive
Quantity: 5 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
LIDOCAINE HYDROCHLORIDEActive
Quantity: 4.5 g in 100 g
Code: V13007Z41A
Classification: ACTIR
INDIAN FRANKINCENSE OILInactive
Code: 5T1XCE6K8K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT