Permethrin
Permethrin Cream, 5%*
Approved
Approval ID
0494e7d2-70a5-44e5-a026-559fdf1808dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Permethrin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-159
Application NumberANDA076369
Product Classification
M
Marketing Category
C73584
G
Generic Name
Permethrin
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 10, 2012
FDA Product Classification
INGREDIENTS (13)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PERMETHRINActive
Quantity: 50 mg in 1 g
Code: 509F88P9SZ
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMER HOMOPOLYMER TYPE BInactive
Code: HHT01ZNK31
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT