Basic Information
Rhofade
71180-003
Regulatory Information
71180-003
NDA208552
C73594
November 30, 2018
USA
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
HUMAN PRESCRIPTION DRUG LABEL
3
Company Information
032365882
Active Ingredients
Inactive Ingredients
TRISODIUM CITRATE DIHYDRATE
Code: B22547B95K
Class Code: IACT
ANHYDROUS CITRIC ACID
Code: XF417D3PSL
Class Code: IACT
butylated hydroxytoluene
Code: 1P9D0Z171K
Class Code: IACT
EDETATE DISODIUM
Code: 7FLD91C86K
Class Code: IACT
lanolin
Code: 7EV65EAW6H
Class Code: IACT
medium-chain triglycerides
Code: C9H2L21V7U
Class Code: IACT
diisopropyl adipate
Code: P7E6YFV72X
Class Code: IACT
oleyl alcohol
Code: 172F2WN8DV
Class Code: IACT
polyethylene glycol 300
Code: 5655G9Y8AQ
Class Code: IACT
ceteareth-6
Code: 2RJS3559D3
Class Code: IACT
glycol stearate
Code: 0324G66D0E
Class Code: IACT
PEG-6 stearate
Code: 8LQC57C6B0
Class Code: IACT
cetostearyl alcohol
Code: 2DMT128M1S
Class Code: IACT
stearyl alcohol
Code: 2KR89I4H1Y
Class Code: IACT
ceteareth-25
Code: 8FA93U5T67
Class Code: IACT
methylparaben
Code: A2I8C7HI9T
Class Code: IACT
propylparaben
Code: Z8IX2SC1OH
Class Code: IACT
phenoxyethanol
Code: HIE492ZZ3T
Class Code: IACT
water
Code: 059QF0KO0R
Class Code: IACT
PEG-32 stearate
Code: 33GX5WQC0M
Class Code: IACT
Active Moieties
oxymetazoline
Code: 8VLN5B44ZY