olopatadine hydrochloride ophthalmic solution, usp 0.2%

olopatadine hydrochloride ophthalmic solution, usp 0.2%
SPL v2
SPL
SPL Set ID 0988e6e2-59a9-47dc-9386-9e9ea877e6c1
Route
ophthalmic
Published
Effective Date 2025-02-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
olopatadine (2 mg)
Inactive Ingredients
benzalkonium chloride edetate disodium sodium phosphate, dibasic, anhydrous sodium chloride hydrochloric acid sodium hydroxide water povidone k30

Identifiers & Packaging

Marketing Status
anda active Since 2025-05-01

Purpose

Antihistamine 

Description

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


Medication Information

Warnings

For external use only

Purpose

Antihistamine 

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.

Description

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

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

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

Questions?

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

Use(s)

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

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

Active Ingredient(s)

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

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.


Structured Label Content

Warnings (WARNINGS)

For external use only

Purpose (PURPOSE)

Antihistamine 

Directions (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 (Other information)

▪ only for use in the eye 

▪ Store between 4°C to 25°C (39°F to 77°F) 

Inactive Ingredients (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.

Principal Display Panel (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

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

Questions?

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

Use(s) (USE(S))

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

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

Active Ingredient(s) (ACTIVE INGREDIENT(S))

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

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 

Stop Use and Ask Doctor If (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 (KEEP OUT OF REACH OF CHILDREN)


If swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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