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NDC 51801-0009-40 GloStrips 1 mg/1 Details
GloStrips 1 mg/1
GloStrips is a OPHTHALMIC STRIP in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nomax Inc.. The primary component is FLUORESCEIN SODIUM.
Product Information
| NDC | 51801-0009 |
|---|---|
| Product ID | 51801-009_be8f6626-961d-48c3-ba7f-a2fae87c4cb6 |
| Associated GPIs | 86806010106120 |
| GCN Sequence Number | 006834 |
| GCN Sequence Number Description | fluorescein sodium STRIP 1 MG OPHTHALMIC |
| HIC3 | Q2U |
| HIC3 Description | EYE DIAGNOSTIC AGENTS |
| GCN | 27831 |
| HICL Sequence Number | 002908 |
| HICL Sequence Number Description | FLUORESCEIN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | GloStrips |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluorescein Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | STRIP |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | FLUORESCEIN SODIUM |
| Labeler Name | Nomax Inc. |
| Pharmaceutical Class | Diagnostic Dye [EPC], Dyes [MoA] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51801-0009-40 (51801000940)
| NDC Package Code | 51801-009-40 |
|---|---|
| Billing NDC | 51801000940 |
| Package | 100 POUCH in 1 CARTON (51801-009-40) / 1 STRIP in 1 POUCH |
| Marketing Start Date | 2013-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d06a4432-c76c-4e2a-abec-6bc5b4e82d51 Details
SPL UNCLASSIFIED SECTION
INDICATIONS
DIRECTIONS FOR USE
To ensure full fluorescence and patient comfort, the GloStrip® impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application.
Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.
INSTRUCTIONS FOR OPENING STERILE GLOSTRIPS®
| 1.Grasp free tab ends of wrapping and slowly pull apart. When the white paper handle becomes visible, remove the GloStrip® from the envelope. |  |
An Alternate Method of Opening
| 1.Grasp envelope firmly with two hands as shown in Fig. 2 below. Tear the envelope from both its edges to the strip handle. |  |
| 2. Hold the handle end of the GloStrip® with the left hand and the paper envelope without holding the tip with the right hand. See Fig. 3 |  |
| 3. Separate the envelope at the tear, exposing the GloStrip® tip. See Fig. 4 |  |
PRINCIPAL DISPLAY PANEL - 300 Strip Carton
INGREDIENTS AND APPEARANCE
| GLOSTRIPS
fluorescein sodium strip |
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| Labeler - Nomax Inc. (103220273) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Nomax Inc. | 103220273 | MANUFACTURE(51801-009) | |
Revised: 12/2019
Document Id: be8f6626-961d-48c3-ba7f-a2fae87c4cb6
Set id: d06a4432-c76c-4e2a-abec-6bc5b4e82d51
Version: 2
Effective Time: 20191223