Akten Gel 3.5% Lidocaine Gel 1mL

NDC: 82584-792-25

Akten (Lidocaine HCl 3.5%) Ophthalmic Gel, 1 mL — Théa Pharma Inc.

Active ingredients	Lidocaine hydrochloride 3.5% (35 mg/mL)
Dosage form	Ophthalmic gel
Route	Topical ophthalmic
Size	1 mL single-patient-use tube
Manufacturer	Théa Pharma Inc.
NDC	82584-792-25

Indications and Usage

An amide local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures, in adult and pediatric patients.

Dosage and Administration

The recommended dose is 2 drops applied to the ocular surface in the area of the planned procedure. The gel may be reapplied as needed to maintain the anesthetic effect. It is administered by a healthcare provider.

Warnings and Precautions

• Not for injection or intraocular administration
• Prolonged use may cause permanent corneal damage
• Patients should not touch the eye for at least 10 to 20 minutes after application
• Not intended for patient self-administration

Contraindications

None.

Adverse Reactions

The most common adverse reactions include conjunctival hyperemia, corneal epithelial changes, headache, and a burning sensation upon application.

Storage and Handling

Store at 15°C to 25°C (59°F to 77°F) in the original carton, protected from light. Discard after use.

How Supplied

Supplied as a clear ophthalmic gel in single-patient-use 1 mL tubes, available individually or in cartons of 25 tubes.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.