AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUS THEA PHARMA INC. FDA Approved AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% contains lidocaine hydrochloride, an amide local anesthetic, as a sterile ophthalmic gel for topical ophthalmic use. AKTEN does not contain an anti-microbial preservative. Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) monohydrochloride with a molecular formula of C 14 H 22 N 2 O ∙ HCl and molecular weight of 270.8. The structural formula of the active ingredient is: Each mL of AKTEN contains 35 mg of lidocaine hydrochloride as the active ingredient. Inactive ingredients: hypromellose, sodium chloride, and water for injection. The pH may be adjusted to 5.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. AKTEN does not contain an anti-microbial preservative. Chemical Structure
FunFoxMeds box
Route
OPHTHALMIC
Applications
NDA022221

Drug Facts

Composition & Profile

Strengths
3.5 % 1 ml 25 unit
Quantities
1 ml 25 pack
Treats Conditions
11 Description Akten Lidocaine Hydrochloride Ophthalmic Gel 3 5 Contains Lidocaine Hydrochloride An Amide Local Anesthetic As A Sterile Ophthalmic Gel For Topical Ophthalmic Use Akten Does Not Contain An Anti Microbial Preservative Lidocaine Hydrochloride Is Designated Chemically As Acetamide 2 Diethylamino N 2 6 Dimethylphenyl Monohydrochloride With A Molecular Formula Of C 14 H 22 N 2 O Hcl And Molecular Weight Of 270 8 The Structural Formula Of The Active Ingredient Is Each Ml Of Akten Contains 35 Mg Of Lidocaine Hydrochloride As The Active Ingredient Inactive Ingredients Hypromellose Sodium Chloride And Water For Injection The Ph May Be Adjusted To 5 5 To 7 5 With Hydrochloric Acid And Or Sodium Hydroxide Akten Does Not Contain An Anti Microbial Preservative Chemical Structure

Identifiers & Packaging

Container Type BOX
UPC
0382584792015
UNII
EC2CNF7XFP
Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel in single-patient-use tubes as follows: NDC 82584-792-01 1 mL fill in a white polyfoil tube Made in Switzerland NDC 82584-792-25 Package of 25 units of 1 mL fill in a white polyfoil tube Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.; PRINCIPAL DISPLAY PANEL - 1 mL Tube Carton NDC 82584-792-01 Akten ® (lidocaine hydrochloride ophthalmic gel) 3.5% For Topical Ophthalmic Use Only Rx only 1mL Sterile PRESERVATIVE FREE For Single-Patient Use Only. Discard Unused Portion. Théa akten 1g

Package Descriptions
  • 16 HOW SUPPLIED/STORAGE AND HANDLING AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel in single-patient-use tubes as follows: NDC 82584-792-01 1 mL fill in a white polyfoil tube Made in Switzerland NDC 82584-792-25 Package of 25 units of 1 mL fill in a white polyfoil tube Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.
  • PRINCIPAL DISPLAY PANEL - 1 mL Tube Carton NDC 82584-792-01 Akten ® (lidocaine hydrochloride ophthalmic gel) 3.5% For Topical Ophthalmic Use Only Rx only 1mL Sterile PRESERVATIVE FREE For Single-Patient Use Only. Discard Unused Portion. Théa akten 1g

Overview

AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% contains lidocaine hydrochloride, an amide local anesthetic, as a sterile ophthalmic gel for topical ophthalmic use. AKTEN does not contain an anti-microbial preservative. Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) monohydrochloride with a molecular formula of C 14 H 22 N 2 O ∙ HCl and molecular weight of 270.8. The structural formula of the active ingredient is: Each mL of AKTEN contains 35 mg of lidocaine hydrochloride as the active ingredient. Inactive ingredients: hypromellose, sodium chloride, and water for injection. The pH may be adjusted to 5.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. AKTEN does not contain an anti-microbial preservative. Chemical Structure

Dosage & Administration

Not available

Warnings & Precautions
No warnings available yet.
Contraindications

None. None. ( 4 )

Storage & Handling

Storage Store at 15°C to 25°C (59°F to 77°F). Keep single-patient-use tubes closed and protected from light in the original carton until ready for use. Discard after use.


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →