Olopatadine Hydrochloride Solution/ Drops
FDA Label NDC 70069-491

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Somerset Therapeutics, Llc for the product Olopatadine Hydrochloride (NDC 70069-491). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Drug Facts

Active Ingredients
Purpose
Olopatadine 0.2%
(equivalent to olopatadine
hydrochloride 0.222%)
Antihistamine

Indications & Usage

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

Warnings

Warnings

For external use only

Otc - Do Not Use

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.

Dosage & Administration

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

Storage And Handling

Other information 

  • only for use in the eye
  • store between 2°-25°C (36°-77°F)

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions?

Customer Care # 1-800-417-9175

Other

Manufactured for:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

Code No.:KR/DRUGS/KTK/28/289/97

1201094

ST-OLO12/P/00

Package Label.Principal Display Panel

Container Label

NDC 70069-491-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Sterile

2.5 mL (0.085 FL OZ)

Image (F19c5298 B566 4416 A345 C5334c6a7ad7 17)

Image (F19c5298 B566 4416 A345 C5334c6a7ad7 17)

Carton Label

 

Original Prescription Strength

NDC 70069-491-01

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

ONCE DAILY

Works in Minutes

Relief from Allergens:

• Pet Dander

• Pollen

• Grass

• Ragweed

 

Sterile

2.5 mL (0.085 FL OZ)

Image (F19c5298 B566 4416 A345 C5334c6a7ad7 18)

Image (F19c5298 B566 4416 A345 C5334c6a7ad7 18)

* Please review the disclaimer below.