Label: CLEAR EYES COOLING ITCHY EYE RELIEF- naphazoline hydrochloride and glycerin and zinc sulfate liquid

  • NDC Code(s): 67172-292-01
  • Packager: Prestige Brands Holdings, Inc.
  • 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 28, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Glycerin 0.25%

  • Purpose

    Lubricant

  • Active ingredients

    Naphazoline hydrochloride 0.012%

  • Purpose

    Redness Reliever

  • Active ingredients

    Zinc sulfate 0.25%

  • Purpose

    Astringent

  • Uses

    • For use as a protectant against further irritation or to relieve dryness of the eye.
    • For the temporary relief of burning & irritation due to the 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 of container 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 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.
    • Remove contact lenses before using.
    • Tamper Evident: Do not use if neckband on bottle is broken or missing.
  • Inactive ingredients

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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NEW Clear eyes® 
    COOLING COMFORT
    Astringent/Lubricant/Redness Relief Eye Drops
    ITCHY EYE RELIEF
    Cools Eye Irritations
    Relieves Itching &Burning
    STERILE 0.5 FL OZ (15 ML)

    PRINCIPAL DISPLAY PANEL NEW Clear eyes® COOLING COMFORT ITCHY EYE RELIEF STERILE 0.5 FL OZ (15 ML)

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES COOLING ITCHY EYE RELIEF 
    naphazoline hydrochloride and glycerin and zinc sulfate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-292
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.12 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 mg  in 1 mL
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BETADEX (UNII: JV039JZZ3A)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-292-011 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen SVP Pty Ltd569162139MANUFACTURE(67172-292)
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