FDA.reportPublic FDA data

Artificial Tears

Manufacturer
MWI | Akorn Operating Company LLC | Akorn
Effective date
2022-02-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:48:08

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 eyes.

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 doctor.

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 eyes.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. 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 doctor.

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:

NDC 13985-600-03

Apexa logo

Artificial Tears STERILE

Ophthalmic Lubricant Ointment

Prevents Irritation and Relieves Dryness of the eye

Can be used at bedtime

AP 704001 Net Weight: 3.5g (1/8 oz)

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:

NDC 13985-600-03

Artificial Tears

Ophthalmic

Lubricant

Ointment

STERILE

Prevents Irritation

and Relieves

Dryness of the eye

Can be used

at bedtime

Apexa logo

AP 704001

Net Weight: 3.5g (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 OintmentPSN5
746083mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic OintmentSCD5
746083mineral oil 15 % / petrolatum, white 83 % Ophthalmic OintmentSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13985-600-032024-01-30C16284748780-11030e365-24c4-111a-e063-dadaa90a10e263284a57-c93d-47a0-8a0f-c583868f19bc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-600-03Artificial Tears3.5 g in 1 TUBEOINTMENT3.55
13985-600-03Artificial Tears1 in 1 CARTONOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-600ARTIFICIAL TEARS (MINERAL OIL AND PETROLATUM) OINTMENT [MWI]5Legacy NDC, 2 package rows20220209_63284a57-c93d-47a0-8a0f-c583868f19bc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGP2
PetrolatumACTIVE INGREDIENT4T6H12BN9U2
Mineral OilACTIVE MOIETYT5L8T28FGP2
PetrolatumACTIVE MOIETY4T6H12BN9U2
LanolinINACTIVE INGREDIENT7EV65EAW6H2

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
13985-60013985-600-03

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

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
LanolinLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LanolinLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact 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
8f691f7d-e1ce-46e1-9709-316c4cfa95b463284a57-c93d-47a0-8a0f-c583868f19bc2022-02-08WarningsExact identifier
spl id: 8f691f7d-e1ce-46e1-9709-316c4cfa95b4
spl set id: 63284a57-c93d-47a0-8a0f-c583868f19bc

Reported adverse events (FAERS/openFDA)#

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