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NDC 62011-0232-01 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 STRATEGIC SOURCING SERVICES LLC. 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: 62011-0232-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 62011-0232 |
|---|---|
| Product ID | 62011-0232_15206723-e08f-429b-a36f-90b73d82af4f |
| 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 | STRATEGIC SOURCING SERVICES LLC |
| 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 62011-0232-01 (62011023201)
| NDC Package Code | 62011-0232-1 |
|---|---|
| Billing NDC | 62011023201 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (62011-0232-1) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2014-02-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 38a248d6-3029-49c9-9198-efc883f2e67f 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
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
NDC 62011-0232-1
Health Mart®
Compare to Zaditor® Active Ingredient*
For Ages 3 Years and Older
Eye Itch Relief
Ketotifen Fumarate
Ophthalmic Solution 0.035%
Antihistamine Eye Drops
Original Prescription Strength
Works in Minutes
Sterile
Up to 12 Hours
30-Day Supply
5 mL (0.17 FL OZ)
INGREDIENTS AND APPEARANCE
| EYE ITCH RELIEF
ketotifen fumarate solution/ drops |
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| Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | MANUFACTURE(62011-0232) , ANALYSIS(62011-0232) , STERILIZE(62011-0232) , PACK(62011-0232) , LABEL(62011-0232) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn AG | 482198285 | MANUFACTURE(62011-0232) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | LABEL(62011-0232) , PACK(62011-0232) | |
Revised: 2/2022
Document Id: 15206723-e08f-429b-a36f-90b73d82af4f
Set id: 38a248d6-3029-49c9-9198-efc883f2e67f
Version: 6
Effective Time: 20220210