Topco Associates LLC. Lubricant Eye Drops Drug Facts

Manufacturer
Topco Associates LLC
Effective date
2019-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:51:01

Label at a glance#

ProductTopcare Lubricant Eye
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure8 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

Storage and handling

• store at 20-25°C (68-77°F) • protect from light

Label contents#

Full prescribing information#

Active ingredients (in each single-use container)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purpose

OTC - PURPOSE SECTION

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
  • do not reuse
  • once opened, discard

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persist 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, calcium chloride dihydrate, hypromellose, magnesium chloride hexahydrate, potassium chloride, sodium chloride, water for injection, zinc chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESERVATIVE-FREE VIALS

Lubricant Eye Drops

POLYETHYLENE GLYCOL 0.4%

PROPYLENE GLYCOL 0.3%

Long lasting relief

Soothing comfort

Dry eye therapy

Actual Size

COMPARE TO Systane® active ingredients

30 SINGLE-USE CONTAINERS 0.01 FL OZ (0.4 mL) EACH STERILE

TopCare Lubricant Eye Drops image
TopCare Lubricant Eye Drops image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-896-65EA - Each36800-896bbfedefa-27fe-474c-b77f-e794238863f312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQ1
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V31
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQ1
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V31
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D41
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I101
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16B1

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
36800-89636800-896-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 · 546 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BORIC ACIDBORIC ACIDR57ZHV85D4MOUTHWASH / BUCCAL7.36 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / DENTALADJ PHExact 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 ACIDQTT17582CBCAPSULE / ORAL7 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR24 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED PELLETS / ORAL3.32 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / NASAL91.7 mg/100mlExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INFILTRATION0.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / OPHTHALMIC0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVESICAL157 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSPRAY, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTABLE, LIPOSOMAL / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION / AURICULAR (OTIC)0.04 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBGEL / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / TOPICAL0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ORAL125 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBLIQUID / NASALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii candidate
134 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
c76c2100-3353-4566-9228-94b56cf494d40cc92ee4-4cd5-4488-9f77-48921297d5012019-12-16WarningsExact identifier
spl id: c76c2100-3353-4566-9228-94b56cf494d4
spl set id: 0cc92ee4-4cd5-4488-9f77-48921297d501

Reported adverse events (FAERS/openFDA)#

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