Olopatadine Hydrochloride Solution
FDA Label NDC 76162-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Olopatadine Hydrochloride (NDC 76162-044). 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 drug facts, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if you experience:, 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

Drug Facts

Active ingredient
Olopatadine (0.2%)
(equivalent to olopatadine hydrochloride, USP 0.222%)

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
  • do not wear a contact lens if your eye is red

Stop Use And Ask A 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 (1-800-222-1222) right away.

Directions

  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(s) once daily, no more than once 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 2° to 25°C (36° to 77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection

Questions?

✆ 1-855-274-4122


DISTRIBUTED BY:
TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO ARHA0323
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com
PRODUCT OF INDIA

Package Label-Principal Display Panel-0.2% (2.5 Ml Container)


+ Top Care®      NDC 76162-044-39
health             ONCE DAILY
Eye Allergy Itch Relief
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%
Antihistamine
STERILE      0.085 FL OZ (2.5 mL)

Package Label-principal Display Panel-0.2% (2.5 mL Container) (Olopatadine Fig1)

Package Label-principal Display Panel-0.2% (2.5 mL Container) (Olopatadine Fig1)


Package Label-Principal Display Panel-0.2% (2.5 Ml Container Carton)


+ TopCare®           NDC 76162-044-39
      health
COMPARE TO PATADAY® ONCE DAILY
RELIEF ACTIVE INGREDIENT*
Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.2%
Eye Allergy
Itch Relief
Antihistamine
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed
                                                 ONCE
                                                DAILY
STERILE             0.085 FL (2.5 mL)


Package Label-principal Display Panel-0.2% (2.5 mL Container Carton) (Olopatadine Fig2)

Package Label-principal Display Panel-0.2% (2.5 mL Container Carton) (Olopatadine Fig2)


* Please review the disclaimer below.