SPL v1
SPL
SPL Set ID f0cc699c-545d-4097-b85d-b67ba550863c
Route
OPHTHALMIC
Published
Effective Date 2025-11-10
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 Sodium Chloride Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-07-15
Description

Active ingredient Olopatadine (0.1%). (equivalent to olopatadine hydrochloride, USP 0.111%)

Purpose

Antihistamine and Redness Reliever

Medication Information

Purpose

Antihistamine and Redness Reliever

Description

Active ingredient Olopatadine (0.1%). (equivalent to olopatadine hydrochloride, USP 0.111%)

Uses

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

Section 42229-5

Distributed by:

Sportpharm

2237 N Commerce Parkway,

STE 1, Weston, Florida-33326

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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
Drug Facts

Active ingredient

Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride, USP 0.111%)

Questions?

✆1-855-274-4122

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

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

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 If
  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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

Section 42229-5 (42229-5)

Distributed by:

Sportpharm

2237 N Commerce Parkway,

STE 1, Weston, Florida-33326

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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
Drug Facts

Active ingredient

Olopatadine (0.1%).

(equivalent to olopatadine hydrochloride, USP 0.111%)

Questions?

✆1-855-274-4122

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

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

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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Label Principal Display Panel (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:01.839326 · Updated: 2026-03-14T23:13:35.542610