SPL v2
SPL
SPL Set ID de5aedb8-8412-a7fd-3451-ca4bbfe8851e
Route
OPHTHALMIC
Published
Effective Date 2023-07-27
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-03-15

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

Questions?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Active Ingredient

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

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 and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

Principal Display Panel



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 Doctor If

you experience:  

  • 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 right away.


Structured Label Content

Uses (USES)

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

Purpose (PURPOSE)

Antihistamine and redness reliever



Warnings (WARNINGS)

For external use only

Directions (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? (QUESTIONS?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Active Ingredient (ACTIVE INGREDIENT)

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

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 and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)



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 Doctor If (STOP USE AND ASK DOCTOR IF)

you experience:  

  • 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 (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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