Optase Hylo Night Eye Ointment

Manufacturer
Scope Health Inc | Regulatory Matters Consulting
Effective date
2026-01-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:36:01

Label at a glance#

ProductOptase
Active ingredientPETROLATUM, LANOLIN
Label structure11 sections

Label contents#

Full prescribing information#

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 right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Retinol Palmitate (Vitamin A)

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Warnings

WARNINGS SECTION

WarningsWarnings

Uses

INDICATIONS & USAGE SECTION

UsesUses

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
White Petrolatum and
mineral oil (91.7%) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Eye Lubricant
Lanolin (6.9%) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Eye Lubricant
Light mineral oil (1.4%) . . . . . . . . . . . . . . . . . . . . . . . . . . . Eye Lubricant

OTC - PURPOSE SECTION

Eye Lubricant

Insert/Instructions - PIL - Page 1

OTHER SAFETY INFORMATION

Optase Hylo PIL Page 1Optase Hylo PIL Page 1

Insert/Instructions- PIL- Page 2

OTHER SAFETY INFORMATION

Optase Hylo PIL Page 2Optase Hylo PIL Page 2

Optase Hylo Night - Outer Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optase HYLO Night BoxOptase HYLO Night Box

Optase Sample Hylo Night - Outer Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optase Sample HYLO Night BoxOptase Sample HYLO Night Box

Optase Hylo Night - Immediate Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optase Hylo Tube- ImmediateOptase Hylo Tube- Immediate

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860004006824GTIN-13: 0860004006824
EAN-13: 0860004006824
GTIN-12: 860004006824
UPC-A: 860004006824
GTIN storage (14 digits): 00860004006824
OPTASE HYLO NIGHT Box 2025 (P).jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72972-003-01Optase1 in 1 BOXOINTMENT16
72972-003-01Optase5 g in 1 TUBEOINTMENT56

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72972-00372972-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
OptaseWHITE PETROLATUM, LANOLINScope Health Incc1991caa-51b9-13d1-e053-2995a90a12932026-01-31WarningsExact identifier
ndc (package): 72972-003-01
ndc (product): 72972-003
ndc11 (package): 72972000301
spl id: 49a98c74-ad18-2e8d-e063-6394a90ac8cb
spl set id: c1991caa-51b9-13d1-e053-2995a90a1293

Reported adverse events (FAERS/openFDA)#

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