Olopatadine Hydrochloride Solution
FDA Label NDC 0363-0200

14 label sections · Submitted to the FDA by Walgreen Co. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Olopatadine Hydrochloride (NDC 0363-0200). 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, uses, 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 (0.1%).
(equivalent to olopatadine hydrochloride, USP 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 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) 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/sodium hydroxide (adjust pH), sodium chloride and water for injection

Questions?

✆1-800-925-4733

Distributed by:
WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

Made in India

Package Label-Principal Display Panel-0.1% (5 Ml Container)

Walgreens
                          NDC 0363-0200-40
Eye Allergy Itch & Redness Relief
OLOPATADINE HYDROCHLORIDE OPHTHALMIC
SOLUTION USP, 0.1%
ANTIHISTAMINE & REDNESS RELIEVER
Twice Daily 5 mL (0.17 FL OZ)

Package Label-principal Display Panel-0.1% (5 mL Container) (Olopatadine Fig1)

Package Label-principal Display Panel-0.1% (5 mL Container) (Olopatadine Fig1)

Package Label-Principal Display Panel-0.1% (5 Ml Container Carton)

ORIGINAL PRESCRIPTION STRENGTH
                                         NDC 0363-0200-40
Walgreens
Compare to the active ingredient in
Pataday® Twice Daily Relief††
Eye Allergy Itch
& Redness Relief
Relief
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 0.1%
ANTIHISTAMINE & REDNESS RELIEVER
TWICE DAILY                               
•  Works in minutes
•  Relief from allergens:
    pet dander, grass,
    pollen & ragweed
•  Sterile
5 mL (0.17 FL OZ)

Package Label-principal Display Panel-0.1% (5 mL Container Carton) (Olopatadine Fig2)

Package Label-principal Display Panel-0.1% (5 mL Container Carton) (Olopatadine Fig2)

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