Permethrin
PERMETHRIN CREAM 5% W/W Rx Only
Approved
Approval ID
a4ebb643-50ee-557f-e053-2995a90a2574
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Permethrin Cream 5% w/w
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-1627
Application NumberANDA211303
Product Classification
M
Marketing Category
C73584
G
Generic Name
Permethrin Cream 5% w/w
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 28, 2022
FDA Product Classification
INGREDIENTS (12)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PERMETHRINActive
Quantity: 50 mg in 1 g
Code: 509F88P9SZ
Classification: ACTIB
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT