FDA.reportPublic FDA data

Artificial Tears Ointment Drug Facts

Manufacturer
Rugby Laboratories Inc.
Effective date
2019-09-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:13:11

Label at a glance#

ProductArtificial Tears
Active ingredientMINERAL OIL, PETROLATUM
Label structure10 sections

Indications and uses

• prevents further irritation • relieves dryness of the eye

Dosage and administration

  pull down the lower lid of the affected eye (s)   apply a small amount (1/4 inch) of ointment to the inside of eyelid

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 15%
White petrolatum 83%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • prevents further irritation
  • relieves dryness of the eye

Warnings

WARNINGS SECTION

When using this product  

  • do not touch tip of container to any surface to avoid contamination

Stop use and ask a doctor if

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • pull down the lower lid of the affected eye (s)
  • apply a small amount (1/4 inch) of ointment to the inside of eyelid

Other information

SPL UNCLASSIFIED SECTION

  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • replace cap after use
  • see crimp of tube or carton for Lot Number and Expiration Date

 

Inactive ingredient

INACTIVE INGREDIENT SECTION

lanolin oil

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

NDC 0536-6550-91

Rugby®

STERILE

Artificial Tears Ointment

Lubricant Ophthalmic Ointment

PRESERVATIVE FREE

Prevents irritation and relieves dryness of the eye

Rugby®

Net Wt. 1/8 oz (3.5 g)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-6550-91GM - Gram0536-65509c9ac14c-9bb3-4e51-83cd-e1e34b55f08c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
LANOLININACTIVE INGREDIENT7EV65EAW6H1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-65500536-6550-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UACTIB

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 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 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
5ab5b131-0979-42d6-b53b-9117e4d3b4f571876336-83de-4baa-a82d-4b056b41bbeb2019-09-06WarningsExact identifier
spl id: 5ab5b131-0979-42d6-b53b-9117e4d3b4f5
spl set id: 71876336-83de-4baa-a82d-4b056b41bbeb

Reported adverse events (FAERS/openFDA)#

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