c4ad0d8e-7539-4dc8-825d-d5e9ff27e488

SPL v2
SPL
SPL Set ID c4ad0d8e-7539-4dc8-825d-d5e9ff27e488
Route
ophthalmic
Published
Effective Date 2023-02-02
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

Purpose

Antihistamine and Redness Reliever

How Supplied

Product: 50090-6341 NDC: 50090-6341-0 5 mL in a BOTTLE, PLASTIC / 1 in a CARTON

Description

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


Medication Information

Warnings

For external use only

Uses

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

Purpose

Antihistamine and Redness Reliever

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

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

How Supplied

Product: 50090-6341

NDC: 50090-6341-0 5 mL in a BOTTLE, PLASTIC / 1 in a CARTON

Description

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

Questions?

✆1-855-274-4122



Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648



Made in India

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%)

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
Olopatadine Hydrochloride
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.


Structured Label Content

Warnings

For external use only

Uses

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

Purpose

Antihistamine and Redness Reliever

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

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

How Supplied (HOW SUPPLIED)

Product: 50090-6341

NDC: 50090-6341-0 5 mL in a BOTTLE, PLASTIC / 1 in a CARTON

Questions?

✆1-855-274-4122



Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648



Made in India

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%)

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
Olopatadine Hydrochloride (OLOPATADINE HYDROCHLORIDE)
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.


Advanced Ingredient Data


Raw Label Data

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