FML (Page 2 of 2)

DOSAGE AND ADMINISTRATION

A small amount (approximately ½ inch ribbon) of ointment should be applied to the conjunctival sac one to three times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

The dosing of FML ® ointment may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

HOW SUPPLIED

FML ® (fluorometholone ophthalmic ointment) 0.1% is supplied in a collapsible aluminum tube with a black low density polyethylene screw cap in the following size: 3.5 g in 3.5 g tube – NDC 0023-0316-04

Storage :

Store at 15°-25°C (59°-77°F). Avoid exposure to temperatures above 40°C (104°F).

Revised : 0 6 /2018

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

© 2018 Allergan. All rights reserved.

FML® is a registered trademark of Allergan, Inc.

Allergan® and its design are trademarks of Allergan, Inc.

v1.0USPI0316

PRINCIPAL DISPLAY PANEL

NDC 0023-0316-04
FML
(fluorometholone
ophthalmic
ointment) 0.1%
Sterile
3.5 g
Rx Only

NDC 0023-0316-04
FML
(fluorometholone 
ophthalmic 
ointment) 0.1%
Sterile
3.5 g
Rx Only
(click image for full-size original)
FML
fluorometholone ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-0316
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOROMETHOLONE (FLUOROMETHOLONE) FLUOROMETHOLONE 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PHENYLMERCURIC ACETATE
MINERAL OIL
PETROLATUM
LANOLIN ALCOHOLS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-0316-04 1 TUBE in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (0023-0316-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017760 12/09/1985
Labeler — Allergan, Inc. (144796497)

Revised: 11/2019 Allergan, Inc.

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