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

  • 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 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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