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NDC 00536-1096-40 Eye Itch Relief 0.35 mg/mL Details
Eye Itch Relief 0.35 mg/mL
Eye Itch Relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. 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: 00536-1096-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 00536-1096 |
|---|---|
| Product ID | 0536-1096_188df731-6f6a-4a79-9464-97d52efd213c |
| Associated GPIs | 86802040102010 |
| 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 Relief |
| 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 | Rugby Laboratories |
| 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 00536-1096-40 (00536109640)
| NDC Package Code | 0536-1096-40 |
|---|---|
| Billing NDC | 00536109640 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (0536-1096-40) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2016-01-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 82a31fcf-b36d-4111-b2bf-6a51a8b6c5da 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:
Rugby® Logo NDC 0536-1096-40
Compare to the active
ingredient in Zaditor®*
Eye Itch
Relief
Ketotifen Fumarate
Ophthalmic Solution 0.035%
ANTIHISTAMINE EYE DROPS
UP TO
12
HOURS
ITCH RELIEF
- Works in minutes
- Original prescription strength
For ages 3 years and older
30-day supply
5 mL (0.17 FL OZ) STERILE
INGREDIENTS AND APPEARANCE
| EYE ITCH RELIEF
ketotifen fumarate solution/ drops |
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| Labeler - Rugby Laboratories (079246066) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | MANUFACTURE(0536-1096) , ANALYSIS(0536-1096) , STERILIZE(0536-1096) , PACK(0536-1096) , LABEL(0536-1096) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn AG | 482198285 | MANUFACTURE(0536-1096) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | LABEL(0536-1096) , PACK(0536-1096) | |
Revised: 2/2022
Document Id: 188df731-6f6a-4a79-9464-97d52efd213c
Set id: 82a31fcf-b36d-4111-b2bf-6a51a8b6c5da
Version: 6
Effective Time: 20220211