GloStrips
GloStrips is an FDA drug label for the active ingredient ROSE BENGAL SODIUM manufactured by Nomax Inc. administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20191223.
- Generic name
- ROSE BENGAL SODIUM
- Manufacturer
- Nomax Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- OPHTHALMIC
- Dosage form
- N/A
- NDC
- 51801-004
- Application
- N/A
- Label effective
- 20191223
About this product
GloStrips is an FDA-registered drug product whose active ingredient is ROSE BENGAL SODIUM. It is labelled by Nomax Inc. taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 51801-004, label effective 20191223. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing ROSE BENGAL SODIUM are most often described in connection with: rose bengal, ophthalmic strips, diagnostic agent, routine ocular, superficial conjunctiva, corneal tissue, change suspected, serve effective. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Indications & 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.
Dosage & 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.
Contraindications
CONTRAINDICATIONS Known hypersensitivity to Rose Bengal.
Recall and safety notices
4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0463-2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40. | Nomax Inc | Class II | Ongoing | 20240501 |
| D-0462-2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123. | Nomax Inc | Class II | Ongoing | 20240501 |
| D-0962-2015 | Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC 51801-004-01), barcode (01)00351801004019, packaged in 100-count strips per carton (NDC 51801-004-40, UPC 3 51801 00440 8), Nomax, Inc., St. Louis, MO 63123 USA. | Nomax Inc | Class III | Terminated | 20150429 |
| D-0961-2015 | Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045. | Nomax Inc | Class III | Terminated | 20150429 |
Frequently asked questions
What is GloStrips used for?
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.
Who makes GloStrips?
Nomax Inc. is the labeler of record for GloStrips.
What form does GloStrips come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is GloStrips prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has GloStrips been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.