FDA.reportPublic FDA data

TopCare Ultra Lubricant

Manufacturer
Topco Associates LLC
Effective date
2016-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:39

Label at a glance#

ProductTopCare Ultra 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%................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.

Do not use

  • if this product changes color 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 fell 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

  • Shake well before using.
  • 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 (20%), hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO UNX416

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

MADE IN KOREA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
36800-68036800-680-15

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
HYDROCHLORIC ACIDQTT17582CBIACT
HYPROMELLOSE 2910 (15000 MPA.S)288VBX44JCIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
ZINC CHLORIDE86Q357L16BIACT

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
c084739e-06dd-f2ea-e053-2a95a90a84c6bca0b579-e133-45c9-a221-8f509961d7072021-04-21WarningsExact identifier
spl set id: bca0b579-e133-45c9-a221-8f509961d707

Reported adverse events (FAERS/openFDA)#

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