Akten Gel

Name: Akten Gel

How Supplied/Storage and Handling

Akten® (lidocaine hydrochloride ophthalmic gel) 3.5% is supplied as a clear gel for single patient use as follows:

NDC 17478-792-01                    1 mL fill in a white polyfoil tube*
NDC 17478-792-25                    Package of 25 units of 1 mL fill in a white polyfoil tube*
                                                        (NDC 17478-792-01)
NDC 17478-792-10                    5 mL fill in a 10 mL natural, round plastic dropper bottle.

Storage

Store at 15° to 25° C (59° to 77° F)

Keep container closed and protected from light in the original carton until use. Discard after use.

AKORN

*Manufactured in Switzerland

Manufactured for:
Akorn, Inc.
Lake Forest, IL 60045
Patent Pending
AEOON

Principal Display Panel Text for Container Label:

NDC 17478-792-01 Akorn Logo

Akten®

(lidocaine HCl

ophthalmic gel) 3.5%

1 mL Sterile Rx only

PRESERVATIVE FREE

Principal Display Panel Text for Carton Label:

NDC 17478-792-01

Akten®

(lidocaine

hydrochloride

ophthalmic

gel) 3.5%

For Topical

Ophthalmic

Use Only

Rx only

1 mL Sterile

PRESERVATIVE FREE

For Single Patient Use Only.

Discard Unused Portion.

Akorn Logo

AKTEN 
lidocaine hydrochloride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-792
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride Anhydrous (Lidocaine) Lidocaine Hydrochloride Anhydrous 35 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Hypromelloses  
Sodium Chloride  
Sodium Hydroxide  
Hydrochloric Acid  
Water  
Packaging
# Item Code Package Description
1 NDC:17478-792-01 1 TUBE in 1 CARTON
1 1 mL in 1 TUBE
2 NDC:17478-792-25 25 TUBE in 1 CARTON
2 1 mL in 1 TUBE
3 NDC:17478-792-10 1 BOTTLE, DROPPER in 1 CARTON
3 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022221 10/08/2008
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 603980319 MANUFACTURE(17478-792), ANALYSIS(17478-792), STERILIZE(17478-792), PACK(17478-792), LABEL(17478-792)
Revised: 04/2014   Akorn, Inc.
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