FDA Label for Olopatadine
View Indications, Usage & Precautions
Olopatadine Product Label
The following document was submitted to the FDA by the labeler of this product Somerset Therapeutics, 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.
Otc - Purpose
Drug Facts
| Active Ingredients | Purpose |
| Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%) | Antihistamine and Redness Reliever |
Indications & Usage
Use temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
Warnings
Warnings
For external use only
Otc - 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
- 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
When using this product
Otc - Stop Use
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
Otc - 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.
Dosage & Administration
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
Storage And Handling
Other information
- only for use in the eye
- store between 4°-25°C (39°-77°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride and water for injection
Otc - Questions
Questions?
Customer Care # 1-800-417-9175
Other
Manufactured for:
Somerset Therapeutics, LLC
Somerset, NJ 08873
Made in India
Code No.:KR/DRUGS/KTK/28/289/97
ST-OLP11-OTC/P/01
1200809
Package Label.Principal Display Panel
Container Label
NDC 70069-017-01
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
TWICE DAILY RELIEF
Eye Allergy Itch & Redness Relief
Sterile
5 mL (0.017 FL OZ)
Carton Label
Original Prescription Strength
NDC 70069-017-01
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
TWICE DAILY RELIEF
Eye Allergy Itch & Redness Relief
TWICE DAILY
Works in Minutes
Relief from Allergens:
• Pet Dander
• Pollen
• Grass
• Ragweed
Sterile
5 mL (0.017 FL OZ
* Please review the disclaimer below.
