Ketotifen Fumarate Solution
FDA Label NDC 76385-106

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unichem Pharmaceuticals (usa), Inc. for the product Ketotifen Fumarate (NDC 76385-106). 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, stop use and ask a doctor if, 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

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Inactive Ingredients

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

Questions?

Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.

Code No.: GO/DRUGS/557

Manufactured For:
Bayshore Pharmaceuticals
LLC., Short Hills, NJ 07078
Made in India.

Principal Display Panel - Bottle Label

NDC 76385-106-17

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ)

Sterile

Ketotifenfumaratelabel (Ketotifenfumaratelabel)

Ketotifenfumaratelabel (Ketotifenfumaratelabel)

Principal Display Panel - Bottle Carton

NDC 76385-106-17

Now OTC

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

5 mL (0.17 FL OZ)

Sterile

Ketotifenfumaratecarton (Ketotifenfumaratecarton)

Ketotifenfumaratecarton (Ketotifenfumaratecarton)

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