FDA.reportPublic FDA data

Industrial Strength Eye Drops

Manufacturer
Honeywell Safety Products USA, INC
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:07:41

Label at a glance#

ProductIndustrial Strength Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400
Label structure9 sections

Indications and uses

relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Label contents#

Full prescribing information#

Industrial Strength Eye Drops Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Industrial Strength Eye Drops Purpose

OTC - PURPOSE SECTION

Eye lubricant

Redness reliever

Industrial Strength Eye Drops Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

Industrial Strength Eye drops Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • overuse may produce increased redness of the eye
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Industrial Strength Eye Drops Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Industrial Strength Eye Drops Other information

SPL UNCLASSIFIED SECTION

store at 15° to 30°C (59° to 86°F)

Tamper evident. Do not use this product if imprinted neckband is missing or broken.

Industrial Strength Eye Drops Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Industrial Strength Eye Drops Questions?

OTC - QUESTIONS SECTION

1-800-430-5490

Industrial Strength Eye Drops Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Industrial Eye DropsIndustrial Eye Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996209polyethylene glycol 400 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN7
996209polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD7
996209PEG 400 1 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0162-15Industrial Strength Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS157
0498-0162-15Industrial Strength Eye Drops1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0162INDUSTRIAL STRENGTH EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL) SOLUTION/ DROPS [HONEYWELL SAFETY PRODUCTS USA, INC]7Legacy NDC, 2 package rows20240123_8edb420c-2229-b240-e053-2995a90afc05.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0498-01620498-0162-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB

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
0f8c3259-7ffa-2e42-e063-6394a90a30e68edb420c-2229-b240-e053-2995a90afc052024-01-22WarningsExact identifier
spl id: 0f8c3259-7ffa-2e42-e063-6394a90a30e6
spl set id: 8edb420c-2229-b240-e053-2995a90afc05

Reported adverse events (FAERS/openFDA)#

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