DermaRad Relief
DermaRad Relief Topical Rehydrating Emulsion
Approved
Approval ID
d5e11f73-918b-eeac-e053-2995a90a4a83
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 6, 2025
Manufacturers
FDA
RENU LABORATORIES, LLC
DUNS: 119451815
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Emulsion
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76348-720
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine Emulsion
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 6, 2025
FDA Product Classification
INGREDIENTS (32)
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
DIHYDROEUGENOLInactive
Code: A3XE712277
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PPG-51/SMDI COPOLYMERInactive
Code: KQ9JG3O3YA
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ALLANTOINActive
Quantity: 1.18 g in 118 mL
Code: 344S277G0Z
Classification: ACTIB
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
DIMETHYL ISOSORBIDEInactive
Code: SA6A6V432S
Classification: IACT
ISOEUGENYL ACETATEInactive
Code: 9DF21GI8W6
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Inactive
Code: Q7UI015FF9
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT
GLYCERYL STEARATE/PEG-100 STEARATEInactive
Code: RD25J5V947
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
SODIUM PYRROLIDONE CARBOXYLATEInactive
Code: 469OTG57A2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINEActive
Quantity: 4.72 g in 118 mL
Code: 98PI200987
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)Inactive
Code: 9M44R3409A
Classification: IACT