Label: CLEAR EYES REDNESS RELIEF- naphazoline hydrochloride and glycerin 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 September 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Clear Eyes Redness Relief

    Drug Facts

  • Active Ingredients

    Glycerin 0.25%

  • Purpose

    Lubricant

  • Active Ingredients

    Naphazoline hydrochloride 0.012%

  • Purpose

    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 temporary 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 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 4 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

    Clear Eyes Redness Relief, Handy Pocket Pal

    Drug Facts

  • Active Ingredients

    Glycerin 0.25%

  • Purpose

    Lubricant

  • Active Ingredients

    Naphazoline hydrochloride 0.012%

  • Purpose

    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.
    •
    Temporarily relieves 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 

    •
    To avoid contamination, do not touch tip to any surface.
    •
    Replace cap after using.
    •
    Overuse may cause 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 Between 20° -25°C (68° -77°F)
    •
    Remove contact lenses before using.

    Relabeled By: Preferred Pharmaceuticals Inc.

  • Inactive Ingredients

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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL


    Clear eyes REDNESS RELIEF
    LUBRICANT/REDNESS RELIEVER EYE DROPS
    Sterile 0.5 FL OZ (15 mL)

    Clear Eyes
  • INGREDIENTS AND APPEARANCE
    CLEAR EYES REDNESS RELIEF 
    naphazoline hydrochloride and glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7611(NDC:67172-797)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.12 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 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:68788-7611-11 in 1 BOX02/07/2020
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/07/2020
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7611)
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