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  5. Label Information: Leader Dry Eye Relief Eye Drops

FDA Label for Leader Dry Eye Relief Eye Drops

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Dry Eye Relief Eye Drops Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%


Otc - Purpose



​Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant


Indications & Usage



​Uses

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation

Warnings



​Warnings

For external use only


Otc - Do Not Use



Do not use this product if solution changes color or becomes cloudy


Otc - When Using



When using this product

  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • remove contact lens before using

Otc - Stop Use



Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed
  • Children under 6 years of age, ask doctor

Other Safety Information



Other information

Store at 15o-30oC (59o-86oF)


Inactive Ingredient



​Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic 


Otc - Questions



Questions or comments?  Call 1-888-527-4276


Package Label.Principal Display Panel




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