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  5. Label Information: Sunmark Dry Eye Relief

FDA Label for Sunmark Dry Eye Relief

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 - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunmark Dry Eye 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.

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 - Ask Doctor



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 - When Using



When using this product

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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children

If accidentally swallowed get medical help or contact a Poison Control Center immediately


Otc - Pregnancy Or Breast Feeding



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


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

RETAIN THIS CARTON FOR FUTURE REFERENCE

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


Inactive Ingredient



​Inactive ingredients

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


Package Label.Principal Display Panel




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