Cetacaine Topical Anesthetic
Cetacaine Topical Anesthetic GEL
Approved
Approval ID
9777acbb-8166-4734-9932-dc66b05bfcb5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2022
Manufacturers
FDA
Cetylite Industries, Inc.
DUNS: 001283704
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine, Butamben, and Tetracaine Hydrochloride
PRODUCT DETAILS
NDC Product Code10223-0221
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJanuary 17, 2022
Generic NameBenzocaine, Butamben, and Tetracaine Hydrochloride
INGREDIENTS (8)
BenzocaineActive
Quantity: 0.028 g in 0.2 g
Code: U3RSY48JW5
Classification: ACTIB
ButambenActive
Quantity: 0.004 g in 0.2 g
Code: EFW857872Q
Classification: ACTIB
Tetracaine HydrochlorideActive
Quantity: 0.004 g in 0.2 g
Code: 5NF5D4OPCI
Classification: ACTIB
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
SaccharinInactive
Code: FST467XS7D
Classification: IACT
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Mecetronium bromideInactive
Code: 7ZNQ7FIO9K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzocaine, Butamben, and Tetracaine Hydrochloride
PRODUCT DETAILS
NDC Product Code10223-0217
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJanuary 17, 2022
Generic NameBenzocaine, Butamben, and Tetracaine Hydrochloride
INGREDIENTS (8)
BenzocaineActive
Quantity: 0.028 g in 0.2 g
Code: U3RSY48JW5
Classification: ACTIB
ButambenActive
Quantity: 0.004 g in 0.2 g
Code: EFW857872Q
Classification: ACTIB
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
SaccharinInactive
Code: FST467XS7D
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Tetracaine HydrochlorideActive
Quantity: 0.004 g in 0.2 g
Code: 5NF5D4OPCI
Classification: ACTIB
Mecetronium bromideInactive
Code: 7ZNQ7FIO9K
Classification: IACT