MedPath
FDA Approval

Rhofade

October 31, 2019

HUMAN PRESCRIPTION DRUG LABEL

Oxymetazoline(1 g in 100 g)

Registrants (1)

DPT Laboratories, Ltd.

832224526

Manufacturing Establishments (1)

DPT Laboratories, Ltd.

Aclaris Therapeutics, Inc.

DPT Laboratories, Ltd.

832224526

Products (1)

Rhofade

71180-003

NDA208552

NDA (C73594)

TOPICAL

November 30, 2018

TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
Code: K89MJ0S5VYClass: ACTIBQuantity: 1 g in 100 g
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
lanolinInactive
Code: 7EV65EAW6HClass: IACT
medium-chain triglyceridesInactive
Code: C9H2L21V7UClass: IACT
diisopropyl adipateInactive
Code: P7E6YFV72XClass: IACT
oleyl alcoholInactive
Code: 172F2WN8DVClass: IACT
polyethylene glycol 300Inactive
Code: 5655G9Y8AQClass: IACT
ceteareth-6Inactive
Code: 2RJS3559D3Class: IACT
glycol stearateInactive
Code: 0324G66D0EClass: IACT
PEG-6 stearateInactive
Code: 8LQC57C6B0Class: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
ceteareth-25Inactive
Code: 8FA93U5T67Class: IACT
methylparabenInactive
Code: A2I8C7HI9TClass: IACT
propylparabenInactive
Code: Z8IX2SC1OHClass: IACT
phenoxyethanolInactive
Code: HIE492ZZ3TClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
PEG-32 stearateInactive
Code: 33GX5WQC0MClass: IACT
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