Eye Drops Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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

Carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-0940
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-0940-9415 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/201103/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/07/201103/31/2018
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