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  5. Label Information: Eye Itch Relief

FDA Label for Eye Itch Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eye Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient



Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)


Purpose



Antihistamine


Use



Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.


Warnings



For external use only


Do Not Use



  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When Using This Product



  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • replace cap after each use

Otc - Stop Use



Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts for more than 72 hours

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • Adults and children 3 years of age and older:
    Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age:
    Consult a doctor.

Other Information



  • only for use in the eye.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients



Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.


Otc - Questions



Questions or comments?

1-800-932-5676

Serious side effects associated with use of this product may be reported to this number


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

Health Mart®

NDC 62011-0232-1

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Sterile

5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label:

NDC 62011-0232-1

Health Mart®

Compare to Zaditor® Active Ingredient*

For Ages 3 Years and Older

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Original Prescription Strength

Works in Minutes

Sterile

Up to 12 Hours

30-Day Supply

5 mL (0.17 FL OZ)


* Please review the disclaimer below.