Olopatadine Hydrochloride Solution
FDA Label NDC 68001-674

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Olopatadine Hydrochloride (NDC 68001-674). 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 Ingredients

  • Purpose

Olopatadine 0.2%
(equivalent to olopatadine hydrochloride 0.222%)

Antihistamine

Indications & Usage

Usetemporarily relieves itchy 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 ifyou 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) 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°C to 25°C (36°F to 77°F)

Inactive Ingredients

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

Questions?

In the U.S., call toll free weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Manufactured by: SamChunDang Pharm. Co., Ltd.
71 Jeyakgongdan-2Gil; Hyangnam-eup, Hwaseong,
Gyeonggi 18622, Korea, South (KOR)
For BluePoint Laboratories

Product of Spain

Rev 08/25

Principal Display Panel

Original Prescription Strength

ONCE DAILY RELIEF

Olopatadine hydrochloride ophthalmic solution 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL

NDC: 68001-674-92

Label

Original Prescription Strength

ONCE DAILY RELIEF

Olopatadine hydrochloride ophthalmic solution 0.2%
Antihistamine
Eye Allergy Itch Relief

STERILE
2.5 mL

NDC: 68001-674-92

Carton

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