FDA.reportPublic FDA data

Artificial tears

Manufacturer
Butler Animal Health Supply, LLC dba Covetrus North America | Akorn Operating Company LLC | Akorn | Croda Europe Ltd.
Effective date
2022-02-08
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:41:19

Label at a glance#

ProductArtificial tears
Active ingredientMineral Oil, Petrolatum
Label structure10 sections

Indications and uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Dosage and administration

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a veterinarian.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 15%

White petrolatum 83%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

OTC - STOP USE SECTION

Stop use and ask a veterinarian if condition persists or increases discontinue use and consult veterinarian.

Keep out of the reach of children.

SPL UNCLASSIFIED SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a veterinarian.

Other information

OTHER SAFETY INFORMATION

  • Store at 20° to 25°C (68° to 77°F) [see USP controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • Retain this carton for future reference.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Lanolin 2%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

covetrus logo

NDC: 11695-6832-1 Reorder #048272

Artificial tears

Lubricant ophthalmic ointment For ophthalmic use only

For veterinary use Net Wt 3.5 g (1/8 oz) Sterile

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

covetrus logo

NDC: 11695-6832-1

Artificial

tears

Lubricant ophthalmic

ointment

For

veterinary

use

Sterile

Net Wt 3.5 g (1/8 oz)

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
746083mineral oil 15 % / petrolatum 83 % Ophthalmic OintmentPSN3
746083mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic OintmentSCD3
746083mineral oil 15 % / petrolatum, white 83 % Ophthalmic OintmentSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-6832-1Artificial tears1 in 1 CARTONOINTMENT13
11695-6832-1Artificial tears3.5 g in 1 TUBEOINTMENT3.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11695-6832ARTIFICIAL TEARS (MINERAL OIL, PETROLATUM) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA]32 package rows20220209_ec073766-70e5-42bd-965b-ce03eaa7d886.zip

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
11695-683211695-6832-1

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
Petrolatum4T6H12BN9UACTIB
Lanolin7EV65EAW6HIACT

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsName fallback
brand name: Artificial Tears
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsName fallback
generic name: MINERAL OIL
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsName fallback
brand name: Artificial Tears
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsName fallback
generic name: MINERAL OIL
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsName fallback
generic name: MINERAL OIL

Reported adverse events (FAERS/openFDA)#

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