MedPath
FDA Approval

Oxymetazoline Hydrochloride

October 8, 2021

HUMAN PRESCRIPTION DRUG LABEL

Oxymetazoline(10 mg in 1 g)

Manufacturing Establishments (1)

Taro Pharmaceuticals Inc.

Taro Pharmaceuticals U.S.A., Inc.

206263295

Products (1)

Oxymetazoline Hydrochloride

51672-1405

ANDA213584

ANDA (C73584)

TOPICAL

October 8, 2021

ceteareth-6Inactive
Code: 2RJS3559D3Class: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1SClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
propylparabenInactive
Code: Z8IX2SC1OHClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58XClass: IACT
Code: K89MJ0S5VYClass: ACTIBQuantity: 10 mg in 1 g
butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
ceteareth-25Inactive
Code: 8FA93U5T67Class: IACT
anhydrous citric acidInactive
Code: XF417D3PSLClass: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72XClass: IACT
edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
lanolinInactive
Code: 7EV65EAW6HClass: IACT
polysorbate 60Inactive
Code: CAL22UVI4MClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
methylparabenInactive
Code: A2I8C7HI9TClass: IACT
oleyl alcoholInactive
Code: 172F2WN8DVClass: IACT
phenoxyethanolInactive
Code: HIE492ZZ3TClass: IACT
polyethylene glycol 300Inactive
Code: 5655G9Y8AQClass: IACT
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