Family Care Ultra Lubricant Eye Drops 588 (NBE Systane Ultra)

Manufacturer
United Exchange Corp.
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:39:20

Label at a glance#

ProductFamily Care Ultra Lubricant
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients Purpose

Polyethylene Glycol 400 0.4%....................... Eye lubricant

Propylene Glycol 0.3%....................................Eye lubricant

OTC - PURPOSE SECTION

Uses

  • for the temporary relief of burning and irritation due to:
  • dryness of the eyes
  • exposure to wind or sun

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 is this product

OTC - WHEN USING SECTION

When using this product

  • remove contact lenses before use
  • replace cap after each use
  • do not touch tip of bottle to any surface to avoid contamination

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience eye pain and/or vision change
  • you continue to have eye redness and/or irritation
  • irritation, burning persists or worsens for more than 72 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzalkonium chloride, boric acid, hypromellose, hydrochloric acid, potassium chloride, purified water, sodium chloride, sodium hydroxide

DOSAGE & ADMINISTRATION SECTION

Distributed by:

United Exchange Corp,

Cypress, CA 90630 USA

1-888-645-8204

Made in South Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

588588

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130780707005880GTIN-13: 0780707005880
EAN-13: 0780707005880
GTIN-12: 780707005880
UPC-A: 780707005880
GTIN storage (14 digits): 00780707005880
588.1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-58865923-588-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-07-26full-release2026-06-01 00:16:06

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
52bdb3d9-a056-5860-e063-6294a90af6da1e2da97c-68a3-9a70-e063-6394a90a4fd42026-05-26WarningsExact identifier
spl set id: 1e2da97c-68a3-9a70-e063-6394a90a4fd4

Reported adverse events (FAERS/openFDA)#

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