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  5. Label Information: Olopatadine Hydrochloride

FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. DO NOT USE
    5. WHEN USING THIS PRODUCT
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Bluepoint Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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