Kovanaze

Effective Date

November 16, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tetracaine(30 mg in 1 mL)

Oxymetazoline(0.5 mg in 1 mL)

Products (1)

NDC Product Code

69803-100

Application Number

NDA208032

Marketing Category

NDA (C73594)

Route of Administration

NASAL

Effective Date

November 16, 2018

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 5NF5D4OPCIClass: ACTIBQuantity: 30 mg in 1 mL

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive

Code: S38J6RZN16Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

Code: K89MJ0S5VYClass: ACTIBQuantity: 0.5 mg in 1 mL

Warnings and Precautions, Methemoglobinemia ( 5.1) 11/2018