Olopatadine Hcl

Olopatadine Hcl
SPL v6
SPL
SPL Set ID e314e745-1e83-a530-e053-2995a90a67b4
Route
OPHTHALMIC
Published
Effective Date 2022-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-07-05

Description

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

Purpose

Antihistamine and redness reliever


Medication Information

Purpose

Antihistamine and redness reliever

Description

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

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 opthalmic 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 1-866-747-7365

Active Ingredient

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride, USP 0.111%)

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

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

Principle Display Panel

Manufactured for:

SOLA Pharmaceuticals LLC,

Baton Rouge, LA 70810

Made in India

Code No: DD/DRUGS/DD/292

Olopatadine Hcl Opthalmic Solution 0.1% Bottle Label:

Olopatadine Hcl Opthalmic Solution 0.1% Carton Label:

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 Our of 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 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 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 opthalmic 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 1-866-747-7365

Active Ingredient

Olopatadine (0.1%)

(equivalent to olopatadine hydrochloride, USP 0.111%)

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

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

Principle Display Panel

Manufactured for:

SOLA Pharmaceuticals LLC,

Baton Rouge, LA 70810

Made in India

Code No: DD/DRUGS/DD/292

Olopatadine Hcl Opthalmic Solution 0.1% Bottle Label:

Olopatadine Hcl Opthalmic Solution 0.1% Carton Label:

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 Our of Reach of Children. (Keep our of 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

All Sections (JSON)