CareOne Lubricant Eye Drops 0.5oz (NBE Systane)

Manufacturer
FOODHOLD U.S.A., LLC
Effective date
2017-11-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:09:53

Label at a glance#

ProductCareOne Lubricant
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure11 sections

Storage and handling

Other information Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 eye

WARNINGS SECTION

Warnings

For external use only

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) gets worse, persists 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 or 2 drops in the affected eye(s) as needed.

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredients

boric acid, calcium chloride, chlorhexidine gluconate, hydrochloric acid, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

DOSAGE & ADMINISTRATION SECTION

Distributed by:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

© 2017 S&S Brands, LLC

Quality guaranteed or

your money back.

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-50641520-506-15

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

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
d1061d4f-d218-4790-e053-2995a90aae7be7d8ee80-bf08-457d-81b4-b22937f2ab1b2021-11-17WarningsExact identifier
spl set id: e7d8ee80-bf08-457d-81b4-b22937f2ab1b

Reported adverse events (FAERS/openFDA)#

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