EYE DROPS- tetrahydrozoline hydrochloride solution/ drops

Eye Drops by

Drug Labeling and Warnings

Eye Drops by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Tetrahydrozoline HCl 0.05%

PURPOSE

Purpose

Redness reliever

INDICATIONS & USAGE

Uses

relieves redness of the eye due to minor eye irritations

WARNINGS

Warnings

For external use only

Do not use if solution changes color or becomes cloudy

Ask a doctor before use if you have narrow angle glaucoma

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

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EYE DROPS 
tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0161
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0161-15	1 in 1 CARTON	07/04/2018
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/04/2018

Labeler - Honeywell Safety Products USA, INC (079287321)