Label: EYES IRRITATION RELIEF- polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 30, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Polyvinyl alcohol 0.5%

  • Active ingredients

    Povidone 0.6%

  • Purpose

    Lubricant

  • Active ingredient

    Tetrahydrozoline hydrochloride 0.05%

  • Purpose

    Redness reliever

  • Uses

    • for the temporary relief of burning & irritation due to dryness of the eye
    • for use as a protectant against further irritation or to relieve dryness of the eye
    • relieves redness of the eye due to minor eye irritations
  • Warnings

    For external use only

    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

    • to avoid contamination, do not touch tip to any surface
    • replace cap after using
    • overuse may produce increased redness of the eye
    • pupils may become enlarged temporarily

    Stop use & ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens
    • symptoms last for more than 72 hours

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

  • Other information

    • store at room temperature
    • remove contact lenses before using
  • Inactive ingredients

    Benzalkonium Chloride,  Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    EYES IRRITATION RELIEF 
    polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0087
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
    TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MANNITOL (UNII: 3OWL53L36A)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0087-11 in 1 BOX03/09/2021
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/09/2021
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
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