Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID e513d024-f121-495e-9957-f2e1da272a48
Route
OPHTHALMIC
Published
Effective Date 2022-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (1 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Hydrochloric Acid Sodium Hydroxide Sodium Chloride Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-09-01

Description

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

Purpose

Antihistamine and redness reliever


Medication Information

Purpose

Antihistamine and redness reliever

Description

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

Use

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 51945-4

Principal Display Panel Text for Container Label:

NDC 17478-308-05

Olopatadine HCl Ophthalmic

Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

STERILE 5 mL (0.17 FL OZ)

Warnings

For external use only

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
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
Questions?

Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

Active Ingredient

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)

Other Information
  • only for use in the eye
  • store at 4° to 25°C (39° to 77°F).
Inactive Ingredients

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

When Using the 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

Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 51945-4 (51945-4)

Principal Display Panel Text for Container Label:

NDC 17478-308-05

Olopatadine HCl Ophthalmic

Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

STERILE 5 mL (0.17 FL OZ)

Purpose

Antihistamine and redness reliever

Warnings

For external use only

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
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
Questions?

Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

Active Ingredient (Active ingredient)

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)

Other Information (Other information)
  • only for use in the eye
  • store at 4° to 25°C (39° to 77°F).
Inactive Ingredients (Inactive ingredients)

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

When Using the Product (When using the 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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)