Label: CLEAR EYES REDNESS RELIEF EYE DROPS STERILE- glycerin, naphazoline hydrochloride 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 February 6, 2022

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  • Drug Facts

  • Active ingredients

    Glycerin 0.25%

    Naphazoline hydrochloride 0.012%

    Purpose

    Lubricant

    Redness reliever

  • Uses

    • for the relief of redness of the eye due to minor eye irritations
    • for the temporary relief of burning and irritations due to dryness of the eye
    • for use as a protectant against further irritation or to relieve 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 produce increased redness of the eye
    • pupils may become temporarily enlarged

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

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

  • Questions?

    1-877-274-1787

    Cleareyes.com

  • Package Labeling:

    Front LabelLabel3

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES REDNESS RELIEF EYE DROPS STERILE 
    glycerin, naphazoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63471-3005(NDC:67172-797)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 mg  in 1 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.12 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:63471-3005-22 in 1 CARTON04/27/2011
    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 finalpart34904/27/2011
    Labeler - Geodis Logistics LLC (877844097)
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