Ofloxacin: Package Insert and Label Information (Page 2 of 2)

ADVERSE REACTIONS

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 received.

Refer to WARNINGS for additional adverse reactions.

DOSAGE AND ADMINISTRATION

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

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 through treatment completion	Instill one to two drops, four times daily.

HOW SUPPLIED

Ofloxacin Ophthalmic Solution USP, 0.3% is supplied sterile in plastic dropper bottles of the following sizes:

• 5 mL — NDC 68071-1607-5

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

AKORN

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

LX00N Rev. 11/16

OFLOXACIN ofloxacin solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1607(NDC:17478-713) Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OFLOXACIN (OFLOXACIN) OFLOXACIN 3 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER BENZALKONIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68071-1607-5 5 mL in 1 BOX None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076407 07/01/2008

Labeler — NuCare Pharmaceuticals, Inc. (010632300)

Establishment
Name	Address	ID/FEI	Operations
NuCare Pharmaceuticals. Inc.		010632300	relabel (68071-1607)

Revised: 02/2021 NuCare Pharmaceuticals, Inc.