Leader ™

Leader ™
SPL v2
SPL
SPL Set ID d91a3512-b87b-4950-b41d-8d094c0e2c38
Route
OPHTHALMIC
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-04-15

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%)

Uses

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

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
  • 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
  • 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
Questions?

Call1-877-758-1480

Active Ingredient

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)

Other Information
  • only for use in the eye
  • store between 4-25 °C (39-77 °F)
  • protect from light
Inactive Ingredients

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses

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

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
  • 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
  • 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
Questions?

Call1-877-758-1480

Active Ingredient (Active ingredient)

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride 0.111%)

Other Information
  • only for use in the eye
  • store between 4-25 °C (39-77 °F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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