Ophthalmic Use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been reported.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
|Days 1 and 2||Instill one to two drops every two to four hours in the affected eye(s).|
|Days 3 through 7||Instill one to two drops four times daily.|
|The recommended dosage regimen for the treatment of bacterial corneal ulcer is:|
|Days 1 and 2||Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops.|
|Days 3 through 7 to 9||Instill one to two drops hourly, while awake.|
|Days 7 to 9 throughtreatment completion||Instill one to two drops, four times daily.|
Ofloxacin Ophthalmic Solution 0.3% is supplied sterile in a labeled translucent LDPE bottle with insert cap assembly comprising of tan colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust cover sealing the bottle cap.
5 mL in 5 mL bottle NDC 55545-1003-1
10 mL in 10 mL bottle NDC 55545-1003-2
Note: Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
B-8, MIDC Industrial Area,
Waluj, Aurangabad — 431 136,
Rising Pharmaceuticals, Inc Allendale, NJ 07401
INSTRUCTIONS FOR USE
Please follow these instructions carefully when using Ofloxacin Ophthalmic Solution.
Use Ofloxacin ophthalmic solution as prescribed by your doctor.
1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after the use of Ofloxacin ophthalmic solution.
2. Wash hands before each use.
3. Before using the medication for the first time, be sure the dust cover seal is unbroken.
4. Refer (I-VI)
5. OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECOME CONTAMINATED BY COMMON BACTERIA KNOWN TO CAUSE EYE INFECTIONS. SERIOUS DAMAGE TO THE EYE AND SUBSEQUENT LOSS OF VISION MAY RESULT FROM USING CONTAMINATED OPHTHALMIC MEDICATIONS. IF YOU THINK YOUR MEDICATION MAY BE CONTAMINATED, OR IF YOU DEVELOP AN EYE INFECTION, CONTACT YOUR DOCTOR IMMEDIATELY CONCERNING CONTINUED USE OF THIS BOTTLE.
6. Repeat (V) and (VI) with the other eye if instructed to do by your doctor.
7. The insert tip is designed to provide a premeasured drop; therefore, do NOT enlarge the hole of the insert tip.
8. After you have used all doses, there will be some Ofloxacin Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Ofloxacin Ophthalmic Solution has been added and you will get the full amount of Ofloxacin Ophthalmic Solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.
WARNING: KEEP OUT OF REACH OF CHILDREN.
IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF OFLOXACIN OPHTHALMIC SOLUTION, PLEASE CONSULT YOUR DOCTOR.
FDC Limited NDC 55545-1003-1
Ofloxacin Ophthalmic Solution 0.3% 10 mL Container
FDC Limited NDC 55545-1003-2
Ophthalmic Solution USP
Rx Only 0.3%
Active: Ofloxacin USP 0.3%
Preservative: Benzalkonium Chloride (0.005%)
Usual Dosage: See package insert.
FOR TOPICAL OPHTHALMIC USE ONLY
Retain in carton until contents are used. Protect from light.
|OFLOXACIN ofloxacin solution|
|Labeler — FDC Limited (650441301)|
|Registrant — FDC Limited (650078413)|
|FDC Limited||862267994||analysis (55545-1003), manufacture (55545-1003)|
Revised: 11/2017 FDC Limited
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.