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  5. Label Information: Olopatadine Hydrochloride

FDA Label for Olopatadine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL

Olopatadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. 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.

Active Ingredient(S)



Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%) 


Purpose



Antihistamine 


Use(S)



temporarily relieves itchy 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 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.


Directions



▪ adults and children 2 years of age and older:
▪ put 1 drop in the affected eyes(s) once daily, no more than once 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°C to 25°C (39°F to 77°F) 


Inactive Ingredients



anhydrous dibasic sodium phosphate, benzalkonium chloride 0.01%, edetate disodium, povidone, sodium chloride, hydrochloric acid/sodium hydroxide (adjust pH) and water for injection.


Questions?



Contact Rising Pharma Holdings, Inc. at 1-844-474-7464


Principal Display Panel



Rising                                  NDC 16571-861-25

Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%

ONCE DAILY RELIEF Antihistamine

NOW AVAILABLE without a prescription
ONCE DAILY 

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:
•Pet Dander

•Pollen

•Grass

•Ragweed

2.5 mL                 STERILE

olapatadine-0.2-carton.jpg - olapatadine 0.2 carton

olapatadine-0.2-carton.jpg - olapatadine 0.2 carton

Rising                            NDC 16571-861-25

Olopatadine Hydrochloride Ophthalmic Solution, USP
0.2%
ONCE DAILY RELIEF Antihistamine
Eye Allergy Itch Relief
ONCE DAILY
2.5 mL 
STERILE


* Please review the disclaimer below.