Cetacaine Anesthetic
Cetacaine Topical Anesthetic Spray and Liquid
Approved
Approval ID
af1773c5-5d5b-4278-b551-30ad2df6d5b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2022
Manufacturers
FDA
Cetylite Industries, Inc.
DUNS: 001283704
Products 1
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10223-0201
Product Classification
G
Generic Name
Benzocaine, Butamben, and Tetracaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (7)
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
Mecetronium bromideInactive
Code: 7ZNQ7FIO9K
Classification: IACT
Tetracaine HydrochlorideActive
Quantity: 0.004 g in 0.2 g
Code: 5NF5D4OPCI
Classification: ACTIB
Dipropylene glycolInactive
Code: E107L85C40
Classification: IACT
SaccharinInactive
Code: FST467XS7D
Classification: IACT
Benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT