FDA.reportPublic FDA data

Com-Pare2 Stye Eye Ointment (Stye TM )

Manufacturer
TRP Company
Effective date
2022-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:43:54

Label at a glance#

ProductStye Eye
Active ingredientMINERAL OIL, PETROLATUM
Label structure9 sections

Indications and uses

• For temporary relief of irritation or dryness in the eye. • May be used as a protectant against further irritation.

Dosage and administration

• Wash your hands. • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.

Storage and handling

• Do not use if bottom ridge of tube is exposed, or if cap or tube is damaged. • See crimp of tube or box for lot number and expiration date. • Store away from heat. • Protect from freezing. • Use before expiration date on the tube. • Store at 59°-86° F (15°- 30°C)

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 31.9%

White Petrolatum 57.7%

PURPOSE

OTC - PURPOSE SECTION

Mineral oil.........Eye lubricant

White petrolatum.....Eye lubricant

USES

INDICATIONS & USAGE SECTION

• For temporary relief of irritation or dryness in the eye.

• May be used as a protectant against further irritation.

WARNINGS

WARNINGS SECTION

  • For use in eyes only.
  • Retain outer carton for full product drug facts.
  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Keep tube tightly closed.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

• If pregnant or breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children.

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

Stop use and ask a doctor if

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.

• The condition worsens or persists for more than 72 hours.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Wash your hands.

• Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• Do not use if bottom ridge of tube is exposed, or if cap or tube is damaged.

• See crimp of tube or box for lot number and expiration date.

• Store away from heat. • Protect from freezing. • Use before expiration date on the tube.

• Store at 59°-86° F (15°- 30°C)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Microcrystalline Wax, Stearic Acid, Wheat Germ Oil.

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?

1-888-969-6855

8am to4 pm; Monday - Friday.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17312-405-322025-12-20C16284748780-11e7a6dab-1f11-a2ce-e063-dadaa90aadf7Com-Pare2 Stye Eye Ointment (Stye TM )
17312-405-322024-07-30C16284748780-11e7a6dab-1f11-a2ce-e063-dadaa90aadf7Com-Pare2 Stye Eye Ointment (Stye TM )

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17312-405STYE EYE (MINERAL OIL, WHITE PETROLATUM OINTMENT) OINTMENT [TRP COMPANY]2Legacy NDC20221221_f037a079-fdbd-3588-e053-2995a90a6621.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-40517312-405-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE WAXXOF597Q3KYIACT
STEARIC ACID4ELV7Z65APIACT
WHEAT GERM OIL14C97E680PIACT
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB

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
43d3bd70-9922-a7e6-e063-6394a90a90eff037a079-fdbd-3588-e053-2995a90a66212025-11-17WarningsExact identifier
spl set id: f037a079-fdbd-3588-e053-2995a90a6621

Reported adverse events (FAERS/openFDA)#

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