Search by Drug Name or NDC
NDC 41250-0303-01 Itchy Eye 0.35 mg/mL Details
Itchy Eye 0.35 mg/mL
Itchy Eye is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is KETOTIFEN FUMARATE.
MedlinePlus Drug Summary
Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.
Related Packages: 41250-0303-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 41250-0303 |
|---|---|
| Product ID | 41250-303_095bec2c-97d8-45a3-be5f-e3601c017a6f |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Itchy Eye |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ketotifen Fumarate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.35 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOTIFEN FUMARATE |
| Labeler Name | Meijer Distribution Inc |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077958 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 41250-0303-01 (41250030301)
| NDC Package Code | 41250-303-01 |
|---|---|
| Billing NDC | 41250030301 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (41250-303-01) / 10 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2016-01-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 11c16152-6feb-45c9-99e3-af514caa2681 Details
Warnings
For external use only
Do not use
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
When using this product
- do not touch tip of container to any surface to avoid contamination
- remove contact lenses before use
- wait at least 10 minutes before reinserting contact lenses after use
- replace cap after each use
Directions
Other information
Inactive ingredients
Questions or comments?
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
NDC 41250-303-01 Compare to Alaway®
active ingredient*
Meijer™ Logo
UP TO 12
HOURS OF RELIEF
Itchy Eye Drops
Ketotifen Fumarate Ophthalmic Solution 0.035%
Antihistamine Eye Drops
Works in Minutes
Original Prescription Strength
For ages 3 years and older
60-day supply
10 mL 0.34 FL OZ STERILE
INGREDIENTS AND APPEARANCE
| ITCHY EYE
ketotifen fumarate solution/ drops |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Meijer Distribution Inc (006959555) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | MANUFACTURE(41250-303) , ANALYSIS(41250-303) , STERILIZE(41250-303) , PACK(41250-303) , LABEL(41250-303) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn AG | 482198285 | MANUFACTURE(41250-303) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | LABEL(41250-303) , PACK(41250-303) | |
Revised: 2/2022
Document Id: 095bec2c-97d8-45a3-be5f-e3601c017a6f
Set id: 11c16152-6feb-45c9-99e3-af514caa2681
Version: 5
Effective Time: 20220211