Rugby Lubricating Drops

Manufacturer
Rugby Laboratories
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:49:01

Label at a glance#

ProductRugby Lubricating Drops
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED
Label structure11 sections

Indications and uses

• for use as a protectant against further irritation or to relieve dryness of the eye • for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

WARNINGS SECTION

  • For external use only

Do Not Use this product

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy

When Using this product

OTC - WHEN USING SECTION

  • remove contact lens before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using.

Keep container tightly closed.

Stop Use and ask a doctor if you experience

OTC - STOP USE SECTION

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • RETAIN CARTON FOR FULL DRUG FACTS INFORMATION

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride (preservative), disodium edetate, purified water, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic.

May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions & comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

TAMPER EVIDENT

SPL UNCLASSIFIED SECTION

Do not use if tape seals on carton top and bottom flaps are damaged or missing.

Distributed by:

RUGBY LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

Made in India

Code: MH/DRUGS/28-KD/283

#302600

Rev. 03/21

R-169

Re-order No. 302600

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1325-94

Polyvinyl

Alcohol 1.4%

Lubricating

Eye Drops

Relieves Dryness

of the Eye

Sterile

0.5 FL OZ (15 mL)

1.4% carton
1.4% carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1325-942024-11-20C16284748780-11030e365-54d8-111a-e063-dadaa90a10e2Rugby Lubricating Eye Drops
0536-1325-942024-01-30C16284748780-11030e365-54d8-111a-e063-dadaa90a10e2Rugby Lubricating Eye Drops

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1325-94ML - Milliliter0536-1325156bc4a3-a756-4307-8d9a-c7ce60d977f912021-12-08

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13250536-1325-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
9d13ab3b-bf0d-4b35-b7a5-4c97dc073365c0549236-9a46-3306-e053-2995a90a20112024-11-20WarningsExact identifier
spl id: 9d13ab3b-bf0d-4b35-b7a5-4c97dc073365
spl set id: c0549236-9a46-3306-e053-2995a90a2011

Reported adverse events (FAERS/openFDA)#

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