ZERVIATE
These highlights do not include all the information needed to use ZERVIATE safely and effectively. See full prescribing information for ZERVIATE . ZERVIATE (cetirizine ophthalmic solution) 0.24%, for topical ophthalmic use Initial U.S. Approval: 1995
Approved
Approval ID
6fc5ef4e-4aea-4c34-8d51-0c07ab9aad59
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2025
Manufacturers
FDA
Harrow Eye, LLC
DUNS: 118526951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cetirizine
PRODUCT DETAILS
NDC Product Code82667-015
Application NumberNDA208694
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateApril 23, 2025
Generic Namecetirizine
INGREDIENTS (11)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETIRIZINEActive
Quantity: 2.4 mg in 1 mL
Code: YO7261ME24
Classification: ACTIB