{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "effective_time": "20191223", "contraindications": [ "CONTRAINDICATIONS Known hypersensitivity to Rose Bengal." ], "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 Fig. 4 Figure Figure Figure Figure" ], "spl_product_data_elements": [ "GloStrips Rose Bengal Sodium Rose Bengal Sodium Rose Bengal AT with tapered end" ], "description": [ "Rose Bengal Ophthalmic Strips diagnostic agent is for professional use only Each strip is impregnated with 1.3 mg of Rose Bengal." ], "openfda": { "brand_name": [ "GloStrips" ], "generic_name": [ "ROSE BENGAL SODIUM" ], "manufacturer_name": [ "Nomax Inc." ], "product_ndc": [ "51801-004" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "OPHTHALMIC" ], "substance_name": [ "ROSE BENGAL SODIUM" ], "spl_id": [ "77d8ad19-ba34-4cd0-9e87-acb2cb9d96b9" ], "spl_set_id": [ "4d5107c6-5077-4006-994f-1cd351775b80" ], "package_ndc": [ "51801-004-40" ], "is_original_packager": [ true ], "unii": [ "956575SN5L" ] }, "version": "3", "dosage_and_administration": [ "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." ], "spl_unclassified_section": [ "Nomax, Inc. • St. Louis, MO 63123 USA Rev. 08/13 MSN 015-059" ], "storage_and_handling": [ "NOTE The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C. CAUTION Take care not to stain clothing." ], "mechanism_of_action": [ "ACTION As a vital stain, Rose Bengal stains both the nuclei and cell walls of dead or degenerated epithelial cells of the cornea and conjunctiva. Rose Bengal will also stain the mucus of the precorneal tear film." ], "how_supplied": [ "HOW SUPPLIED Dispenser carton containing 100 sterile strips." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 100 Strip Carton NDC 51801-004-40 Amcon ® Laboratories, Inc. Rose Bengal GloStrips ® 1.3 mg Rose Bengal Ophthalmic Strips USP 100 Sterile Strips Principal Display Panel - 100 Strip Carton" ], "indications_and_usage": [ "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." ], "instructions_for_use_table": [ "
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 Fig. 4
" ], "set_id": "4d5107c6-5077-4006-994f-1cd351775b80", "id": "77d8ad19-ba34-4cd0-9e87-acb2cb9d96b9" } ] }