Label: CLEAR EYES REDNESS RELIEF HANDY POCKET PAL- naphazoline hydrochloride and glycerin 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 July 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Glycerin 0.25%Lubricant
    Naphazoline hydrochloride 0.012%Redness reliever
  • Uses

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

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

    Stop use and ask doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens or persists 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

  • Inactive ingredients

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

  • Questions?

    1-877-274-1787 www.cleareyes.com

  • SPL UNCLASSIFIED SECTION

    Dist by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Brands Company
    Distributed by Convenience Valet® Melrose Park, IL 60160

  • PRINCIPAL DISPLAY PANEL - 6 mL Bottle Box

    UP TO
    12
    HOURS
    OF
    SOOTHING
    COMFORT

    Clear eyes®

    REDNESS
    RELIEF

    LUBRICANT / REDNESS
    RELIEVER EYE DROPS

    Handy
    Pocket
    Pal®

    PLUS
    RELIEVES

    DRYNESS
    BURNING
    IRRITATIONS

    Children's
    Miracle Network
    Hospitals®

    minimum annual
    $250,000 Donation
    See details on back

    THIS PACKAGE
    FOR HOUSEHOLDS
    WITHOUT YOUNG
    CHILDREN

    STERILE
    0.2 FL OZ (6 mL)

    PRINCIPAL DISPLAY PANEL - 6 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    CLEAR EYES REDNESS RELIEF HANDY POCKET PAL 
    naphazoline hydrochloride and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1139(NDC:67172-796)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.00012 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0025 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-1139-11 in 1 BOX11/01/2012
    16 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34911/01/2012
    Labeler - Mechanical Servants LLC (005530951)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mechanical Servants LLC005530951REPACK(29485-1139) , RELABEL(29485-1139)
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