FREDS ASTRINGENT RDENESS RELIEVER EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [FREDS INC]

FREDS ASTRINGENT RDENESS RELIEVER EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [FREDS INC]
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NDC 55315-124-15
Set ID 206796e8-2ac5-42b1-8d0a-02f49d40f31c
Category HUMAN OTC DRUG LABEL
Packager Freds Inc
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients                                                                                  Purpose

    Tetrahydrozoline HCl 0.05%......................................................Redness Reliever

    Zinc Sulfate 0.25%..............................................................................Astringent

  • PURPOSE

    Uses

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

    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 tips 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 they 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 right away.

  • INDICATIONS & USAGE

    Directions

    • Instill 1 or 2 drops in the affected eye(s) up to 4 times daily
    • Children under 6 years of age: Ask a doctor
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store between 15°-25°C (59°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients benzalkonium chloride, boric acid, disodium edetate hydrate, purified water, sodium chloride, sodium citrate

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Fred's Inc.

    4300 New Getwell Rd.

    Memphis, TN 38118

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    FREDS ASTRINGENT RDENESS RELIEVER EYE 
    tetrahydrozoline hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-124
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 mg  in 1 mg
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE0.25 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    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:55315-124-151 in 1 CARTON
    115 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/30/2013
    Labeler - Freds Inc (005866116)

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