FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

DRUG FACTS
PURPOSE
USES
WARNINGS
DO NOT USE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE:
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 ML CONTAINER)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 ML CONTAINER CARTON)

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts

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

Purpose

Antihistamine and Redness Reliever

Uses

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

Warnings

For external use only

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

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 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 (1-800-222-1222) right away.

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:

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

Questions?

✆1-855-274-4122

Distributed by:
TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO ARHA0323
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com

PRODUCT OF INDIA

Package Label-Principal Display Panel-0.1% (5 Ml Container)

+TopCare_®             NDC 76162-020-40
       health                 TWICE DAILY
Eye Allergy Itch & Redness Relief
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine & Redness Reliever
STERILE            0.17 FL OZ (5 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container) - olopatadine fig1

Package Label-Principal Display Panel-0.1% (5 Ml Container Carton)

                                NDC 76162-020-40
+TopCare_®
        health
COMPARE TO PATADAY^® TWICE DAILY
          RELIEF ACTIVE INGREDIENT*
Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.1%
Eye Allergy Itch
& Redness Relief
Antihistamine & Redness Reliever
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed
                                                        TWICE
                                                           DAILY
STERILE                       0.17 FL OZ (5 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton) - olopatadine fig2

* Please review the disclaimer below.

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