Eye Itch Relief
FDA Label NDC 49348-107

13 label sections · Submitted to the FDA by Strategic Sourcing Services Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Eye Itch Relief (NDC 49348-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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.

Questions Or Comments?

1-800-923-5676

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:

Sunmark Logo®

NDC 49348-107-17

sterile

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Principal Display Panel Text For Container Label (Mck04 0006 01)

Principal Display Panel Text For Container Label (Mck04 0006 01)

Principal Display Panel Text for Carton Label:

Sunmark Logo®

COMPARE TO ZADITOR®

ACTIVE INGREDIENT*

NDC 49348-107-17

sterile

eye itch

relief

ketotifen fumarate

ophthalmic

solution 0.035%

Antihistamine Eye Drops

For ages 3 years and older

30-day supply

Works in minutes

Original Prescription Strength

UP TO 12 HOURS OF RELIEF

5 mL (0.17 FL OZ)

Principal Display Panel Text For Carton Label (Mck04 0006 02)

Principal Display Panel Text For Carton Label (Mck04 0006 02)

* Please review the disclaimer below.