Rugby Lubricating Eye Drops

Manufacturer
Rugby Laboratories | KC Pharmaceuticals, Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:28

Label at a glance#

ProductRugby Lubricating Eye Drops
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Polyethylene glycol 400  0.4%
Propylene glycol   0.3%

OTC - PURPOSE SECTION

Purpose

Polyethylene glycol 400............. Lubricant
Propylene glycol............ Lubricant

INDICATIONS & USAGE SECTION

Uses
• for the temporary relief of burning and irritation due to dryness of the eye

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 in this product

OTC - WHEN USING SECTION

When using this product
• do not touch the 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 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 (1-800-222-1222) right away

DOSAGE & ADMINISTRATION SECTION

Directions
• Instill 1 or 2 drops in the affected eye(s) as needed
• Children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1219-94ML - Milliliter0536-12198837f5c1-d093-4385-bb10-71f96636e5f212019-05-02

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
0536-12190536-1219-94

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 · Source PDF

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
3b569cc9-a9da-fe9f-e063-6394a90a1e57feb5befd-50c2-4e4e-82a8-5c75fc6cc2132025-08-01WarningsExact identifier
spl set id: feb5befd-50c2-4e4e-82a8-5c75fc6cc213

Reported adverse events (FAERS/openFDA)#

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