Ivermectin
These highlights do not include all the information needed to use IVERMECTIN cream safely and effectively. See full prescribing information for IVERMECTIN cream.IVERMECTIN cream, 1%, for topical useInitial U.S. Approval: 1996
Approved
Approval ID
bd0bb2c2-3bc2-4672-9dc1-9ee9b5d70140
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IVERMECTIN
PRODUCT DETAILS
NDC Product Code0574-2107
Application NumberNDA206255
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateFebruary 21, 2023
Generic NameIVERMECTIN
INGREDIENTS (18)
IVERMECTINActive
Quantity: 10 mg in 1 g
Code: 8883YP2R6D
Classification: ACTIB
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 809Y72KV36
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT