Delsam Pharma's ARTIFICIAL EYE OINTMENT

Manufacturer
Delsam Pharma Llc
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:16:40

Label at a glance#

ProductARTIFICIAL EYE
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.

Storage and handling

■ Store at 20° to 25°C (68°-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. KEEP TIGHTLY CLOSED

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 15%

White Petrolatum 83%

PURPOSE

OTC - PURPOSE SECTION

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.

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.

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

Keep out of the 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 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

STORAGE AND HANDLING SECTION

■ Store at 20° to 25°C (68°-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.

KEEP TIGHTLY CLOSED

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lanolin 2%

Questions or comments?

OTC - QUESTIONS SECTION

1-866-826-1309 between 9am and 4pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

lubricant

Eye Ointment

Can Be Used at Bedtime

Sterile

FOR OPHTHALMIC USE ONLY

READ OUTER CARTON FOR INFORMATION BEFORE USING

Distributed By:

Delsam Pharma Lic

Bronx, Newyork 10467.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72570-122-35GM - Gram72570-122440ead0b-81d6-4157-862d-730bbf16d3d512021-07-15

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
72570-12272570-122-35

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c9c04828-f37d-4004-9be0-878323761a0f9bb21174-5901-46ed-9bd1-d8e7f1f38faf2023-03-15WarningsExact identifier
spl set id: 9bb21174-5901-46ed-9bd1-d8e7f1f38faf

Reported adverse events (FAERS/openFDA)#

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