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NDC 51801-0004-40 GloStrips 1.3 mg/1 Details
GloStrips 1.3 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 ROSE BENGAL SODIUM.
Product Information
| NDC | 51801-0004 |
|---|---|
| Product ID | 51801-004_77d8ad19-ba34-4cd0-9e87-acb2cb9d96b9 |
| Associated GPIs | 86806030006110 |
| 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 | GloStrips |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Rose Bengal Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | STRIP |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1.3 |
| Active Ingredient Units | mg/1 |
| Substance Name | ROSE BENGAL SODIUM |
| Labeler Name | Nomax Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51801-0004-40 (51801000440)
| NDC Package Code | 51801-004-40 |
|---|---|
| Billing NDC | 51801000440 |
| Package | 100 POUCH in 1 CARTON (51801-004-40) / 1 STRIP in 1 POUCH |
| Marketing Start Date | 2013-08-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4d5107c6-5077-4006-994f-1cd351775b80 Details
SPL UNCLASSIFIED SECTION
ACTION
INDICATIONS
Rose Bengal ophthalmic strips are used as a diagnostic agent in routine ocular examinations or when superficial conjunctiva or corneal tissue change is suspected. Rose Bengal ophthalmic strips can also serve as an effective aid in the diagnosis of keratoconjunctivitis sicca, keratitis, abrasions or corrosions as well as the detection of foreign bodies.
DIRECTIONS FOR USE
To ensure optimal staining and patient comfort, the GloStrip impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application. Shake off excess solution and touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.
NOTE
INSTRUCTIONS FOR USE
| 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. | Fig. 1 |
| 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. | Fig. 2 |
| 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 | Fig. 3 |
| 3.Separate the envelope at the tear, exposing the GloStrip® tip. See Fig. 4 |
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PRINCIPAL DISPLAY PANEL - 100 Strip Carton
INGREDIENTS AND APPEARANCE
| GLOSTRIPS
rose bengal sodium strip |
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| Labeler - Nomax Inc. (103220273) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Nomax Inc. | 103220273 | MANUFACTURE(51801-004) | |