Eye Allergy Itch Relief

Eye Allergy Itch Relief
SPL v3
SPL
SPL Set ID 355df5ce-95e2-4d05-9114-a3190d934d3a
Route
OPHTHALMIC
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (2 mg)
Inactive Ingredients
Povidone, Unspecified Sodium Phosphate, Dibasic, Unspecified Form Sodium Chloride Edetate Disodium Benzalkonium Chloride Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-04-15

Description

Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%)

Uses

temporarily relieves itchy 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) 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
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 1-800-910-6874

Active Ingredient

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)

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, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection

Principle Display Panel

NDC: 82442-967-02

20077500

JE61705

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
Keep Out Reach of Children.

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

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

Structured Label Content

Uses

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

Purpose

Antihistamine

Warnings

For external use only

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
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 1-800-910-6874

Active Ingredient (Active ingredient)

Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride 0.222%)

Other Information (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, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection

Principle Display Panel

NDC: 82442-967-02

20077500

JE61705

When Using This Product (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
Keep Out Reach of Children. (Keep out reach of children.)

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

Stop Use and Ask A Doctor If You Experience: (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

Advanced Ingredient Data


Raw Label Data

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