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NDC 30142-0702-01 Eye Itch 0.35 mg/mL Details
Eye Itch 0.35 mg/mL
Eye Itch is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Company. 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: 30142-0702-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 30142-0702 |
|---|---|
| Product ID | 30142-702_7047b553-55fc-4714-8457-925ba83c8c10 |
| Associated GPIs | |
| GCN Sequence Number | 043118 |
| GCN Sequence Number Description | ketotifen fumarate DROPS 0.025 % OPHTHALMIC |
| HIC3 | Q6R |
| HIC3 Description | EYE ANTIHISTAMINES |
| GCN | 92451 |
| HICL Sequence Number | 006554 |
| HICL Sequence Number Description | KETOTIFEN FUMARATE |
| Brand/Generic | Generic |
| Proprietary Name | Eye Itch |
| 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 | Kroger Company |
| 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 30142-0702-01 (30142070201)
| NDC Package Code | 30142-702-01 |
|---|---|
| Billing NDC | 30142070201 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (30142-702-01) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2014-01-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1ddf4288-369c-4eea-821d-191dc2b1fe78 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:
COMPARE TO the active ingredient of
Zaditor® *See side panel
NDC 30142-702-01
Kroger Logo
ORIGINAL PRESCRIPTION STRENGTH
STERILE
Eye Itch
Relief Drops
Ketotifen Fumarate
Ophthalmic Solution 0.035%
Antihistamine Eye Drops
- Works in Minutes
- For Ages 3 Years
and Older - 30-Day Supply
LASTS UP TO
12
HOURS
5 mL
(0.17 FL OZ)
INGREDIENTS AND APPEARANCE
| EYE ITCH
ketotifen fumarate solution/ drops |
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| Labeler - Kroger Company (006999528) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | MANUFACTURE(30142-702) , ANALYSIS(30142-702) , STERILIZE(30142-702) , PACK(30142-702) , LABEL(30142-702) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn AG | 482198285 | MANUFACTURE(30142-702) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | LABEL(30142-702) , PACK(30142-702) | |
Revised: 2/2022
Document Id: 7047b553-55fc-4714-8457-925ba83c8c10
Set id: 1ddf4288-369c-4eea-821d-191dc2b1fe78
Version: 6
Effective Time: 20220210