Olopatadine Hydrochloride Solution
FDA Label NDC 51407-938

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Golden State Medical Supply, Inc. for the product Olopatadine Hydrochloride (NDC 51407-938). 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 otc - purpose, indications & usage, warnings, do not use, when using this product, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active Ingredient

Purpose

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

Antihistamine and redness reliever

Indications & Usage

Uses

temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

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

Otc - Stop Use

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

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.

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°C to 25°C (39°F 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 Or Comments?

Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

Product of Spain

07/25

Marketed by:
GSMS, Inc.
Camarillo, CA 93012 USA

Principal Display Panel

NDC 51407-938-05

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Twice Daily Relief
Eye Allergy Itch & Redness Relief

STERILE

5 mL (0.17 FL OZ)


NDC 51407-938-05

Olopatadine HCl Ophthalmic Solution,USP 0.1%

Antihistamine and Redness Reliever

Twice Daily


STERILE
5 mL (0.17 FL OZ)

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