Label: SEASONAL ITCHY AND RED EYE RELIEF- tetrahydrozoline hcl, zinc sulfate liquid

  • NDC Code(s): 67510-0665-1, 67510-0665-5
  • Packager: Kareway Product, 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 February 17, 2023

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  • Active Ingredient

    Tetrahydrozoline HCl 0.05%

    Zinc sulfate 0.25%

  • Purpose

    Redness reliever

    Astringent

  • Use

    • for temporary relief of discomfort and redness of the eye due to minor eye irritations
  • Warnings

    Ask a doctor before use if you have narrow angle glaucoma.

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or become cloudy
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts 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 right away.

  • Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age:  ask a doctor
  • Other information

    • store at 15° to 25°C (59° to 77°F)

  • Inactive ingredients

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

  • package label

    image of carton label

  • INGREDIENTS AND APPEARANCE
    SEASONAL ITCHY AND RED EYE RELIEF 
    tetrahydrozoline hcl, zinc sulfate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0665
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 mg  in 1 mL
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0665-51 in 1 CARTON11/12/2013
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67510-0665-11 in 1 CARTON11/12/2013
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/12/2013
    Labeler - Kareway Product, Inc. (121840057)
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