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NDC 51801-0003-40 GloStrips 0.6 mg/1 Details

GloStrips 0.6 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	51801-0003
Product ID	51801-003_f63dc6e5-6c40-4731-be57-73860ea7a403
Associated GPIs
GCN Sequence Number	006833
GCN Sequence Number Description	fluorescein sodium STRIP 0.6 MG OPHTHALMIC
HIC3	Q2U
HIC3 Description	EYE DIAGNOSTIC AGENTS
GCN	27832
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	0.6
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 51801-0003-40 (51801000340)

Pricing Information	N/A
NDC Package Code	51801-003-40
Billing NDC	51801000340
Package	100 POUCH in 1 CARTON (51801-003-40) / 1 STRIP in 1 POUCH
Marketing Start Date	2013-07-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f5dbf66b-068d-4408-989b-4f29b3c48738 Details

SPL UNCLASSIFIED SECTION

Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use only

Each strip is impregnated with 0.6 mg of fluorescein sodium USP.

INDICATIONS

For staining the anterior segment of the eye in disclosing corneal injury, in applanation tonometry and when fitting contact lenses.

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.

HOW SUPPLIED

Carton containing 100 or 300 sterile strips.

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

NDC 51801-003-50

AMCON®

Laboratories, Inc.

0.6 mg

Fluorescein

GloStrips®

Fluorescein Sodium

Ophthalmic Strips USP

300 Sterile Strips

PRINCIPAL DISPLAY PANEL - 300 Strip Carton

INGREDIENTS AND APPEARANCE

GLOSTRIPS

fluorescein sodium strip

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:51801-003
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR)	FLUORESCEIN	0.6 mg

Product Characteristics
Color	ORANGE, WHITE	Score
Shape	RECTANGLE (with tapered end)	Size	52mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51801-003-50	300 in 1 CARTON	07/30/2013
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:51801-003-40	100 in 1 CARTON	07/30/2013
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		07/30/2013

Labeler - Nomax Inc. (103220273)

Name	Address	ID/FEI	Business Operations
Establishment
Nomax Inc.		103220273	MANUFACTURE(51801-003)

Revised: 12/2019

Document Id: f63dc6e5-6c40-4731-be57-73860ea7a403

Set id: f5dbf66b-068d-4408-989b-4f29b3c48738

Version: 3

Effective Time: 20191223