Label: CLEAR EYES MAXIMUM 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 24, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • 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 the dryness of the eye.
    • for the 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 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 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, edetate disodium, purified water, sodium borate

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Clear
    eyes®
    MAXIMUM
    REDNESS RELIEF
    LUBRICANT/REDNESS
    RELIEVER EYE DROPS
    Sterile 1.0 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL Clear Eyes Maximum Redness Relief 1.0 FL OZ (30 mL)

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES MAXIMUM REDNESS RELIEF 
    naphazoline hydrochloride and glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-494
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.00015 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN.0025 mL  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:67172-494-011 in 1 BOX
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34909/01/2010
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altaire Pharmaceuticals Inc.786790378MANUFACTURE
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!