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

  • NDC Code(s): 67172-696-01, 67172-696-02
  • 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 June 14, 2017

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

  • 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:

    • 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 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

  • PRINCIPAL DISPLAY PANEL

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

    PRINCIPAL DISPLAY PANEL
Clear eyes®
MAXIMUM
REDNESS RELIEF
LUBRICANT/REDNESS
RELIEVER EYE DROPS
STERILE 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES MAXIMUM REDNESS RELIEF 
    naphazoline hydrochloride and glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-696
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-696-011 in 1 CARTON09/01/2010
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:67172-696-021 in 1 CARTON09/01/2010
    215 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 FINALpart34909/01/2010
    Labeler - Prestige Brands Holdings, Inc. (159655021)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aspen SVP Pty Ltd569162139MANUFACTURE(67172-696)