Glostrips®

Drug Facts

Composition & Product

Active Ingredients

Rose Bengal At (1.3 mg)

Identifiers & Packaging

Pill Appearance

Shape: rectangle Color: pink Color: white Size: 52 mm

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2013-08-20

Medication Information

Contraindications

Known hypersensitivity to Rose Bengal.

How Supplied

Dispenser carton containing 100 sterile strips.

Description

Rose Bengal Ophthalmic Strips

diagnostic agent is for professional use only

Each strip is impregnated with 1.3 mg of Rose Bengal.

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.

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.

Section 42229-5

Nomax, Inc. • St. Louis, MO 63123 USA

Rev. 08/13

MSN 015-059

Section 59845-8

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

Caution

Take care not to stain clothing.

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.

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

Structured Label Content

Note (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.

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.

Description (34089-3)

Rose Bengal Ophthalmic Strips

diagnostic agent is for professional use only

Each strip is impregnated with 1.3 mg of Rose Bengal.

Section 42229-5 (42229-5)

Nomax, Inc. • St. Louis, MO 63123 USA

Rev. 08/13

MSN 015-059

Section 59845-8 (59845-8)

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

Caution (CAUTION)

Take care not to stain clothing.

Indications (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.

How Supplied (HOW SUPPLIED)

Dispenser carton containing 100 sterile strips.

Contraindications (CONTRAINDICATIONS)

Known hypersensitivity to Rose Bengal.

Directions for Use (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.

Principal Display Panel 100 Strip Carton (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

Advanced Ingredient Data

[{"name": "Rose Bengal AT", "unii": "1IID5XA5GB", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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.", "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.", "34089-3": "Rose Bengal Ophthalmic Strips diagnostic agent is for professional use only Each strip is impregnated with 1.3 mg of Rose Bengal.", "42229-5": "Nomax, Inc. • St. Louis, MO 63123 USA Rev. 08/13 MSN 015-059", "59845-8": "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", "CAUTION": "Take care not to stain clothing.", "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.", "HOW SUPPLIED": "Dispenser carton containing 100 sterile strips.", "CONTRAINDICATIONS": "Known hypersensitivity to Rose Bengal.", "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.", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information