Label: EYE DROPS- tetrahydrozoline hydrochloride solution/ drops 

  • Label RSS
  • NDC Code(s): 0536-0940-94
  • Packager: Rugby Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/11

If you are a consumer or patient please visit this version.

  • Active ingredient

    Tetrahydrozoline HCl 0.05%

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  • Purpose

    Redness Reliever

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  • Uses

    • relieves redness of the eye due to minor eye irritations
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  • 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
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  • Keep out of reach of children.

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

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  • Directions

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

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

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  • 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.

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  • 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®

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  • INGREDIENTS AND APPEARANCE
    EYE DROPS 
    tetrahydrozoline hcl solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-0940
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID  
    EDETATE DISODIUM  
    SODIUM BORATE  
    SODIUM CHLORIDE  
    WATER  
    BENZALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-0940-94 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 10/07/2011
    Labeler - Rugby Laboratories Inc. (109178264)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 196603781 MANUFACTURE
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