Olopatadine Hydrochloride Solution/ Drops.

Olopatadine Hydrochloride Solution/ Drops.
SPL v4
SPL
SPL Set ID ec0c8c56-68d2-e63e-e053-2995a90a8db2
Route
OPHTHALMIC
Published
Effective Date 2024-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2015-12-07

Description

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)                                  

Purpose

Antihistamine and redness reliever


Medication Information

Purpose

Antihistamine and redness reliever

Description

Olopatadine (01.%) (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 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?

1-800-706-5575

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

Active Ingredient

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

                                 

Other Information

  • Only for use in the eye
  • Store between 4ºC to 25ºC (39ºF to 77ºF)
Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Principal Display Panel

TWICE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

NDC 51407-663-05

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 right away.  


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 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?

1-800-706-5575

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

Active Ingredient (Active ingredient)

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

                                 

Other Information (Other information)

  • Only for use in the eye
  • Store between 4ºC to 25ºC (39ºF to 77ºF)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

Principal Display Panel

TWICE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

NDC 51407-663-05

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. (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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