Label: CAREONE EYE DROPS SEASONAL RELIEF- tetrahydrozoline hcl and zinc sulfate solution/ drops

  • 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 May 1, 2019

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients Purposes

    Tetrahydrozoline HCl 0.05%.......Eye redness reliever

    Zinc sulfate 0.25%......................Eye astringent

  • PURPOSE

    Uses

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

    For external use only

  • ASK DOCTOR

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

  • WHEN USING

    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 becomes cloudy
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • STOP 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • to open bottle, push cap down and twist counterclockwise
    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    • some users may exprience a brief tingling sensation
    • store between 15-25ºC (59-77ºF)
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?

    Call 1-877-846-9949

  • DOSAGE & ADMINISTRATION

    Distributed by:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

  • PRINCIPAL DISPLAY PANEL

    86533.2

  • INGREDIENTS AND APPEARANCE
    CAREONE EYE DROPS SEASONAL RELIEF 
    tetrahydrozoline hcl and zinc sulfate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-653
    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
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-653-151 in 1 BOX10/01/2018
    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 finalpart34909/26/2018
    Labeler - FoodHold U.S.A LLC (809183973)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!