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

Description

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

Purpose

Antihistamine 


Medication Information

Purpose

Antihistamine 

Description

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

Use(s)

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

Warnings

For external use only

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

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

Questions?

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

Other Information

▪ only for use in the eye 

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

Active Ingredient(s)

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

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

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

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

Use(s) (USE(S))

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

Purpose (PURPOSE)

Antihistamine 

Warnings (WARNINGS)

For external use only

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

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

Questions?

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

Other Information (Other information)

▪ only for use in the eye 

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

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

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

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

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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