Olopatadine Hydrochloride Ophthalmic Solution Solution/ Drops
FDA Label NDC 68083-477

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gland Pharma Limited for the product Olopatadine Hydrochloride Ophthalmic Solution (NDC 68083-477). 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, uses, warnings, do not use, when using this product, stop use and ask 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

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

Purpose

Antihistamine and redness reliever


Uses

temporarily relieves itchy and red 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
  • do not wear a contact lens if your eye is red

Stop Use And Ask Doctor If

you experience:  

  • eye pain
  • changes in vision
  • increased 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 2 years of age and older:
• put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
• if using other ophthalmic products while using this product, wait at least 5 minutes between each product
• replace cap after each use  
• children under 2 years of age: consult a doctor

Other Information

• only for use in the eye  
• store between 4° to 25°C (39° to 77°F)

Inactive Ingredients

Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

Questions?

contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Principal Display Panel

NDC 68083-477-01
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP
Bottle Label:

Olopatadine-bottle-label (Olopatadine Bottle Label)

Olopatadine-bottle-label (Olopatadine Bottle Label)



Carton Label:
Olopatadine-carton-label (Olopatadine Carton Label)

Olopatadine-carton-label (Olopatadine Carton Label)


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