Olopatadine Hydrochloride Solution
FDA Label NDC 16571-861

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Olopatadine Hydrochloride (NDC 16571-861). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, when using this product, stop use and ask doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

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.