Label: CLEAR EYES COOLING REDNESS RELIEF- glycerin and naphazoline hydrochloride liquid

  • NDC Code(s): 67172-393-01
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL

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.

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Updated June 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Glycerin 0.5%

  • Purpose

    Lubricant

  • Active ingredients

    Naphazoline hydrochloride 0.03%

  • Purpose

    Redness Reliever

  • Uses

    • for the relief of redness of the eye due to minor eye irritations
    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a protectant against further irritation or 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 of container to any surface
    • replace cap after using
    • overuse may produce increased redness of the eye
    • pupils may become temporarily enlarged

    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 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 20°-25°C (68°-77°F)
    • remove contact lenses before using
  • Inactive ingredients 

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

  • Questions?

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

     

  • PRINCIPAL DISPLAY PANEL

    CLEAR EYES® 
    COOLING
    COMFORT
    Lubricant/Redness Relief Eye Drops
    STERILE 0.5 FL OZ (15 ML)

    PRINCIPAL DISPLAY PANEL CLEAR EYES® COOLING COMFORT Lubricant/Redness Relief Eye Drops STERILE 0.5 FL OZ (15 ML)

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES COOLING REDNESS RELIEF 
    glycerin and naphazoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-393
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.3 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    BETADEX (UNII: JV039JZZ3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-393-011 in 1 BOX02/15/2011
    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 finalpart34902/15/2011
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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