EYE DROPS- tetrahydrozoline hcl solution/ drops
Rugby Laboratories Inc.

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.

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Eye Drops Drug Facts

Active ingredient

Tetrahydrozoline HCl 0.05%

Purpose

Redness Reliever

Uses

•: relieves redness of the eye due to minor eye irritations

Warnings

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

•: do not touch tip of container to any surface to avoid contamination
•: overuse may produce increased redness of the eye
•: pupils may become enlarged temporarily

Stop use and ask a doctor if

•: you experience eye pain, changes in vision, continued redness or irritation of the eye
•: condition worsens or persists for more than 72 hours

Keep out of reach of children.

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

Directions

•: instill 1 to 2 drops in the affected eye(s) up to four times daily

Other information

•: store at 15° - 30°C (59° - 86°F)
•: keep tightly closed
•: replace cap after use

Inactive ingredients

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

Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

PRESERVATIVE: benzalkonium chloride 0.01%

Questions or comments?

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

NDC 0536-0940-94

Rugby®

COMPARED TO ACTIVE INGREDIENT IN VISINE® ORIGINAL*

Eye Drops

Tetrahydrozoline HCl 0.05%
Ophthalmic Solution, USP
Sterile

Redness Reliever

1/2 fl oz (15 mL)

Rugby®

EYE DROPS
tetrahydrozoline hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-0940
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-0940-94	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2011	03/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	10/07/2011	03/31/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019

Document Id: cf69b59e-988e-4302-b951-9ff7e6a69b18

Set id: 7f4b0600-8d8c-40e1-bd95-27020894995e

Version: 2

Effective Time: 20190905

Rugby Laboratories Inc.