Eye drops solution/ drops

Active ingredient

Tetrahydrozoline HCl 0.05%

Purpose

Redness Reliever

Uses

  • relieves redness of the eye due to minor eye irritations

Warnings

Do not useif 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 - 30C (59 - 86F)
  • 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.

Ingredients and appearance - Product information

Eye drops solution/ drops- Tetrahydrozoline hcl

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Tetrahydrozoline hydrochloride ( UNII: 0YZT43HS7D)( Tetrahydrozoline - UNII: S9U025Y077 ) 0.5 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Boric acid ( UNII: R57ZHV85D4)
Edetate disodium ( UNII: 7FLD91C86K)
Sodium borate ( UNII: 91MBZ8H3QO)
Sodium chloride ( UNII: 451W47IQ8X)
Water ( UNII: 059QF0KO0R)
Benzalkonium chloride ( UNII: F5UM2KM3W7)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part349 USA

Labeler - Rugby Laboratories Inc.( 079246066)

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®