SOOLANTRA
These highlights do not include all the information needed to use SOOLANTRA Cream safely and effectively. See full prescribing information for SOOLANTRA Cream.SOOLANTRA (ivermectin) cream, 1%, for topical useInitial U.S. Approval: 1996
Approved
Approval ID
b1d5b166-ab06-4ab5-b0c6-31126238118a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2022
Manufacturers
FDA
Galderma Laboratories, L.P.
DUNS: 047350186
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IVERMECTIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0299-3823
Application NumberNDA206255
Product Classification
M
Marketing Category
C73594
G
Generic Name
IVERMECTIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 17, 2022
FDA Product Classification
INGREDIENTS (18)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 809Y72KV36
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
IVERMECTINActive
Quantity: 10 mg in 1 g
Code: 8883YP2R6D
Classification: ACTIB
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT