MAXITROL
Maxitrol Ointment
Approved
Approval ID
d17cecdb-c7cb-41cc-a11e-00c6ed0dcc11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2020
Manufacturers
FDA
Alcon Laboratories, Inc.
DUNS: 008018525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
neomycin sulfate, polymyxin b sulfate and dexamethasone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-0631
Application NumberNDA050065
Product Classification
M
Marketing Category
C73594
G
Generic Name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 28, 2020
FDA Product Classification
INGREDIENTS (7)
POLYMYXIN B SULFATEActive
Quantity: 10000 [USP'U] in 1 g
Code: 19371312D4
Classification: ACTIM
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
DEXAMETHASONEActive
Quantity: 1 mg in 1 g
Code: 7S5I7G3JQL
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT