FDA.reportPublic FDA data

GNP Lubricant Eye

Manufacturer
Amerisource Bergen
Effective date
2013-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:36:04

Label at a glance#

ProductGNP Lubricant Eye
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure12 sections

Storage and handling

Other information Store at room temperature. Do not use if carton is open or neckband on the bottle is broken or missing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                                              Purpose

Polyethylene Glycol 400 (0.4%).........................................Lubricant

Propylene Glycol (0.3%)....................................................Lubricant

OTC - PURPOSE SECTION

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.

WARNINGS SECTION

Warnings For external use only.

OTC - DO NOT USE SECTION

Do not use

  • if this product changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.

OTC - WHEN USING SECTION

When using this product

  • Do not touch tip of container to any surface to avoid contamination.
  • Replace cap after each use.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you feel eye pain.
  • changes in vision occur.
  • redness or irritation of the eye(s) get worse or lasts more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

  • Instill 1 to 2 drops in the affected eye(s) as needed
  • Children under 6 years of age: Ask a doctor.

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature.
  • Do not use if carton is open or neckband on the bottle is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Boric Avid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hypromellose 2910, Magnesium Chloride, Potassium Chloride, Purified Water, Sodim Chloride, Sodium Hydroxide, Zinc Chloride

DOSAGE & ADMINISTRATION SECTION

Distributed By:

Amerisource Bergen Corporation

1300 Morris Drive

Chesterbrook, PA 19087  

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN3
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD3
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-018-052020-01-31C16284748780-19d75b9d0-128b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-018-05GNP Lubricant Eye15 mg in 1 BOTTLESOLUTION/ DROPS153
46122-018-05GNP Lubricant Eye1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-018GNP LUBRICANT EYE (POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [AMERISOURCE BERGEN]3Legacy NDC, 2 package rows20130712_668c24d6-2722-4488-b9d0-7b47bb87a351.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-018-05ML - Milliliter46122-018491d1c08-7bed-421e-ac2f-73aa78073f4f12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQ3
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V33
POLYETHYLENE GLYCOLSACTIVE MOIETY3WJQ0SDW1A3
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V33
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D43
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M3
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB3
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O3
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I103
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I3
WATERINACTIVE INGREDIENT059QF0KO0R3
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16B3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-01846122-018-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
HYDROCHLORIC ACIDQTT17582CBIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
ZINC CHLORIDE86Q357L16BIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 519 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGRANULE, FOR SUSPENSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRAMUSCULAR9 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, DENTIFRICE / DENTAL0.03 mg/mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE / ORAL60 mgExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRASYNOVIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BSOLUTION / OPHTHALMICNAExact identifier — unii candidate
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INFILTRATION0.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION / INTRATYMPANIC1 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR360 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / RECTALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION / INTRAPERITONEAL0.01 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBTABLET / ORAL2.32 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSPRAY / NASAL10 mlExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBDROPS / NASAL10 mlExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBEMULSION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e0aee839-06bb-4398-aa39-eb623dbfca37668c24d6-2722-4488-b9d0-7b47bb87a3512013-06-30WarningsExact identifier
spl id: e0aee839-06bb-4398-aa39-eb623dbfca37
spl set id: 668c24d6-2722-4488-b9d0-7b47bb87a351

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.