Label: CIRCLE K EYE DROPS REDNESS RELIEVER- tetrahydrozoline hydrochloride solution/ drops

  • NDC Code(s): 66715-5729-4
  • Packager: Lil Drug Store Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tetrahydrozoline HCl 0.05%

  • Purpose

    Redness reliever

  • Uses

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

    For external use only

    Ask a doctor before use if you have narrow angle glaucoma

    When using this product

    • pupils may become enlarged temporarily
    • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
    • if solution changes color or becomes cloudy, do not use
    • overuse may produce increased redness of the eye
    • remove contact lens before using

    Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye, or if 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 (1-800-222-1222) right away.

  • Directions

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

  • Other information

    Store at 59°-86°F (15°-30°C)

  • Inactive ingredients

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

  • Question or comments?

    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM)

  • SPL UNCLASSIFIED SECTION

    Proudly distributed by
    Circle K Stores Inc.

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    REMOVES REDNESS
    FAST ACTING FORMULA
    Compare to the active ingredient
    in Visine® Original*

    Circle K

    sterile

    eye drops

    Tetrahydrozoline HCl 0.05%

    Redness Reliever

    0.5 fl oz (15mL)

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    CIRCLE K EYE DROPS  REDNESS RELIEVER
    tetrahydrozoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5729
    Route of AdministrationTOPICAL
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5729-41 in 1 CARTON05/04/2016
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34905/04/2016
    Labeler - Lil Drug Store Products, Inc (093103646)
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