Equaline Sterile Eye Drops
Equaline Sterile Eye Drops 15mL (PLD)
Approved
Approval ID
31a25efb-a627-1a13-e063-6394a90a2ca3
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
United Natural Foods, Inc.
DUNS: 943556183
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetrahydrozoline HCl
PRODUCT DETAILS
NDC Product Code83455-210
Application NumberM018
Marketing CategoryC200263
Route of AdministrationOPHTHALMIC
Effective DateJanuary 1, 2024
Generic NameTetrahydrozoline HCl
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TETRAHYDROZOLINE HYDROCHLORIDEActive
Quantity: 0.05 g in 100 mL
Code: 0YZT43HS7D
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT