Rhofade
These highlights do not include all the information needed to use RHOFADE topical cream safely and effectively. See full prescribing information for RHOFADE topical cream. RHOFADE (oxymetazoline hydrochloride) cream, 1%, for topical use Initial U.S. Approval: 1964
Approved
Approval ID
8968299e-2a4f-41a8-9088-6343ea6c91f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2019
Manufacturers
FDA
Aclaris Therapeutics, Inc.
DUNS: 032365882
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxymetazoline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71180-003
Application NumberNDA208552
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxymetazoline Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 30, 2018
FDA Product Classification
INGREDIENTS (21)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
oxymetazoline HydrochlorideActive
Quantity: 1 g in 100 g
Code: K89MJ0S5VY
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
lanolinInactive
Code: 7EV65EAW6H
Classification: IACT
medium-chain triglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
diisopropyl adipateInactive
Code: P7E6YFV72X
Classification: IACT
oleyl alcoholInactive
Code: 172F2WN8DV
Classification: IACT
polyethylene glycol 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
ceteareth-6Inactive
Code: 2RJS3559D3
Classification: IACT
glycol stearateInactive
Code: 0324G66D0E
Classification: IACT
PEG-6 stearateInactive
Code: 8LQC57C6B0
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
ceteareth-25Inactive
Code: 8FA93U5T67
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
phenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
PEG-32 stearateInactive
Code: 33GX5WQC0M
Classification: IACT