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  5. Label Information: Leader Eye Itch Relief Drops

FDA Label for Leader Eye Itch Relief Drops

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - DO NOT USE
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. INDICATIONS & USAGE
    8. STORAGE AND HANDLING
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Eye Itch Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Hanlim Pharm. Co., Ltd.. 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.

Otc - Active Ingredient



Active ingredient                                             Purpose

Ketotifen (0.025%)..........................................Antihistamine

(Equivalent to ketotifen fumarate 0.035%)


Otc - Purpose



Use

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


Otc - Do Not Use



Warnings

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

Otc - When Using




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.


Indications & Usage



Directions

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

Storage And Handling



Other information

  • Only for use in the eye
  • Store between 20o-25oC (68o to 77oF) (See USP controlled Room Temperature)
  • Do not use if cap seal ring is broken

Inactive Ingredient



Inactive ingredients

benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and water for injection


Package Label.Principal Display Panel



image of carton label - leadereyeitchrelief

image of carton label - leadereyeitchrelief

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