PEG-Phen Lubricant Eye Drops

Manufacturer
Amerisource Bergen | Akorn, Inc. | Akorn, Inc
Effective date
2013-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:41:04

Label at a glance#

ProductPEG-Phen Lubricant Eye Drops
Active ingredientPolyethylene Glycol 400, Propylene Glycol
Label structure11 sections

Indications and uses

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

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

OTC - PURPOSE SECTION

Lubricant

Lubricant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

SPL UNCLASSIFIED SECTION

STORAGE AND HANDLING SECTION

  • Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Boric Acid, Hypromellose, Sodium Chloride, Potassium Chloride, Zinc Chloride, Calcium Chloride Diydrate, Magnesium Chloride Hexahydrate. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

SPL UNCLASSIFIED SECTION

Preservative: Benzalkonium Chloride.

OTC - QUESTIONS SECTION

FigureFigureQuestions or comments?

1-800-579-8327

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

46122-199-05

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

PEG-Phen Lubricant Eye Drops

Long Lasting

Soothing comfort dry eye therapy

15 mL (0.5 fl oz)

Sterile

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

46122-199-05

Compare to Systane®

active ingredients*

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

PEG-Phen

Lubricant Eye Drops

Long Lasting

Soothing comfort

dry eye therapy

15 mL

(0.5 fl oz)

Sterile

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-199-052020-10-21C16284748780-19d75b9d1-0bee-f424-e053-dadaa90a57cea69e8c58-791b-4923-9810-a406c4dce42e
46122-199-052020-01-31C16284748780-19d75b9d1-0bee-f424-e053-dadaa90a57cea69e8c58-791b-4923-9810-a406c4dce42e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-199-05ML - Milliliter46122-199ac8800d6-c717-478f-b510-05f5fb440bd112013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Polyethylene Glycol 400ACTIVE INGREDIENTB697894SGQ2
Propylene GlycolACTIVE INGREDIENT6DC9Q167V32
Polyethylene Glycol 400ACTIVE MOIETYB697894SGQ2
Propylene GlycolACTIVE MOIETY6DC9Q167V32
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W72
Boric AcidINACTIVE INGREDIENTR57ZHV85D42
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5M2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB2
HypromellosesINACTIVE INGREDIENT3NXW29V3WO2
Magnesium ChlorideINACTIVE INGREDIENT02F3473H9O2
Potassium ChlorideINACTIVE INGREDIENT660YQ98I102
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I2
WaterINACTIVE INGREDIENT059QF0KO0R2
Zinc ChlorideINACTIVE INGREDIENT86Q357L16B2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-19946122-199-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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 10 · 570 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5 mgExact identifier — unii candidate
148 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
17 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSHAMPOO / TOPICAL104 mgExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / URETERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10CAPSULE / ORAL62 mgExact identifier — unii candidate
18 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MCAPSULE / ORAL2 mgExact identifier — unii candidate
16 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION / INTRAPERITONEAL0.01 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBAEROSOL, SPRAY / RESPIRATORY (INHALATION)1.5 %w/wExact identifier — unii candidate
148 equally ranked IID candidates
Potassium ChloridePOTASSIUM CHLORIDE660YQ98I10POWDER / NASALNAExact identifier — unii candidate
18 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAVENOUS720 mgExact identifier — unii candidate
148 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBGEL / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRATHECAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 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
151b3d3b-2045-4ef8-bdcf-a7b6de3931b0a69e8c58-791b-4923-9810-a406c4dce42e2020-10-21WarningsExact identifier
spl set id: a69e8c58-791b-4923-9810-a406c4dce42e

Reported adverse events (FAERS/openFDA)#

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