Eye Drops

Manufacturer: Honeywell Safety Products USA, INC
Effective date: 2024-01-22
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 00:07:41

Label at a glance#

ProductEye Drops

Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE

Label structure10 sections

Storage and handling

Other information S tore at 15° to 30°C (59° to 86°F)

Contacts and useful links#

PhoneLabel contact800-430-5490

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Tetrahydrozoline HCl 0.05%

OTC - PURPOSE SECTION

Purpose

Redness reliever

INDICATIONS & USAGE SECTION

Uses

relieves redness of the eye due to minor eye irritations

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

STORAGE AND HANDLING SECTION

Other information Store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Tamper evident. Do not use this product if imprinted neckband is missing or broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE

Distributed by

North by Honeywell

900 Douglas Pike

Smithfield, RI 02917

Questions? Call 800-430-5490

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eye Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	10
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	10
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	10
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0498-0161-15	Eye Drops	1 in 1 CARTON	SOLUTION/ DROPS	1		10
0498-0161-15	Eye Drops	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0498-0161	EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HONEYWELL SAFETY PRODUCTS USA, INC]	10	Legacy NDC, 2 package rows	20240123_703645d0-5157-7a83-e053-2a91aa0a903e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Eye Drops
Tetrahydrozoline hydrochloride
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
WATER
SODIUM BORATE
SODIUM CHLORIDE
TETRAHYDROZOLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0498-0161	0498-0161-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0f8c13aa-a122-26f8-e063-6394a90a53e8			703645d0-5157-7a83-e053-2a91aa0a903e	2024-01-22	Warnings	Exact identifier spl id: 0f8c13aa-a122-26f8-e063-6394a90a53e8 spl set id: 703645d0-5157-7a83-e053-2a91aa0a903e

Reported adverse events (FAERS/openFDA)#

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