Label: CLEAR EYES COMPLETE 7 SYMPTOM RELIEF- hypromellose and naphazoline hydrochloride and polysorbate 80 and zinc sulfate 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 August 15, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hypromellose 0.20%

  • Purpose

    Lubricant

  • Active Ingredients

    Naphazoline Hydrochloride 0.025%

  • Purpose

    Redness Reliever

  • Active Ingredients

    Polysorbate 80 0.50%

  • Purpose

    Lubricant

  • Active Ingredients

    Zinc Sulfate 0.25%

  • Purpose

    Lubricant

  • 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 of this product 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
    • symptoms last 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

    calcium chloride, citric acid, edetate disodium, magnesium chloride, potassium chloride, purified water, sodium citrate, sodium chloride and sorbic acid.

  • Questions?

    1-877-274-1787

    www.cleareyes.com

  • PRINCIPAL DISPLAY PANEL

    Clear
    eyes     ®
    COMPLETE
    ASTRINGENT/LUBRICANT/REDNESS RELIEVER EYE DROPS
    Sterile 0.5 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL Clear Eyes Complete 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES COMPLETE 7 SYMPTOM RELIEF 
    hypromellose and naphazoline hydrochloride and polysorbate 80 and zinc sulfate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-595
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC SULFATE (UNII: 89DS0H96TB) (ZINC - UNII:J41CSQ7QDS) ZINC SULFATE.625 mL  in 1 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 801.25 mL  in 1 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.0625 mL  in 1 mL
    HYPROMELLOSE (UNII: 3NXW29V3WO) (HYPROMELLOSE - UNII:3NXW29V3WO) HYPROMELLOSE.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-595-011 in 1 BOX
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34903/01/2010
    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!