Tetracaine Hydrochloride
These highlights do not include all the information needed to use TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5% safely and effectively. See full prescribing information for TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%.TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%, for topical ophthalmic use Initial U.S. Approval: 1965
Approved
Approval ID
8352a2c8-15e7-4719-ac06-df10ff6b0568
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2022
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetracaine Hydrochloride
PRODUCT DETAILS
NDC Product Code24208-092
Application NumberNDA210821
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateMay 31, 2022
Generic NameTetracaine Hydrochloride
INGREDIENTS (8)
TETRACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 5NF5D4OPCI
Classification: ACTIB
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT