Lubricant Stye

Manufacturer
AACE PHARMACEUTICALS, INC.
Effective date
2022-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:50:27

Label at a glance#

ProductLubricant Stye
Active ingredientMINERAL OIL, PETROLATUM
Label structure10 sections

Indications and uses

for the temporary relief of discomfort due to minor irritations.

Dosage and administration

pull down the lower lid of the affected eye(s) and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Storage and handling

store at room temperature 15°-30°C (59°-86°F). see the crimp of tube or box for Lot Number and Expiration Date. Use only if tape seals on top and bottom flaps are intact. Do not use if bottom ridge of the tube cap is exposed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 31.9% and White Petrolatum 57.7%

PURPOSE

OTC - PURPOSE SECTION

Emollient

USES

INDICATIONS & USAGE SECTION

  • for the temporary relief of discomfort due to minor irritations.

WARNINGS

WARNINGS SECTION

When using this product

  • avoid contamination, do not touch tip of container to any surface
  • replace cap after use.

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.

Keep this and all drugs out of the reach of children.

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs 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 the lower lid of the affected eye(s) and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F).
  • see the crimp of tube or box for Lot Number and Expiration Date.
  • Use only if tape seals on top and bottom flaps are intact.
  • Do not use if bottom ridge of the tube cap is exposed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Microcrystalline Wax, Stearic Acid, Wheat Germ Oil.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC#: 71406-125-35

Compare to Stye TM Active ingredients*

Lubricant Stye Ointment

Temporarily relieves discomfort due to itching, burning, stinging & other minor irritations

Not a cure for infection

Preservative-free

Net Wt. 0.125 oz (3.5 g) Sterile

Distributed By:

AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

www. aacepharma.com

Rev. 00

This product is not manufactured or distributed by Insight Pharmaceutical Corp., owner of the registered trademark Stye TM

Stye OintmentStye Ointment

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
71406-12571406-125-35

Ingredients#

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

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

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
f1ed2a28-1ebe-bbb3-e053-2a95a90ae6c5a0fc8525-527a-cedd-e053-2a95a90a85122023-01-10WarningsExact identifier
spl set id: a0fc8525-527a-cedd-e053-2a95a90a8512

Reported adverse events (FAERS/openFDA)#

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