Olopatadine Hydrochloride Ophthalmic Solution, Usp 0.1%

Olopatadine Hydrochloride Ophthalmic Solution, Usp 0.1%
SPL v2
SPL
SPL Set ID 7c86e2d4-2d37-4ccf-9227-820a50637778
Route
OPHTHALMIC
Published
Effective Date 2025-04-04
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (1 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Anhydrous Sodium Chloride Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-05-01

Description

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

Purpose

Antihistamine and redness reliever


Medication Information

Purpose

Antihistamine and redness reliever

Description

Olopatadine (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

Use(s)

temporarily relieves itchy and red 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 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 

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 (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

Inactive Ingredients

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

Principal Display Panel

Rising                                  NDC 16571-882-05



Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

NOW AVAILABLE without a prescription

TWICE DAILY 

Eye Allergy Itch & Redness Relief

Works in Minutes Relief from Allergens:

•Pet Dander

•Grass

•Pollen

•Ragweed

5 mL (0.17 FL OZ)                    STERILE

Rising                            NDC 16571-882-05

Olopatadine Hydrochloride Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

TWICE DAILY

5 mL (0.17 FL OZ)

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 and red eyes due to pollen, ragweed, grass, animal hair and dander

Purpose (PURPOSE)

Antihistamine and redness reliever

Warnings (WARNINGS)

For external use only

Directions (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 

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 (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Rising                                  NDC 16571-882-05



Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

NOW AVAILABLE without a prescription

TWICE DAILY 

Eye Allergy Itch & Redness Relief

Works in Minutes Relief from Allergens:

•Pet Dander

•Grass

•Pollen

•Ragweed

5 mL (0.17 FL OZ)                    STERILE

Rising                            NDC 16571-882-05

Olopatadine Hydrochloride Ophthalmic Solution, USP

0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

TWICE DAILY

5 mL (0.17 FL OZ)

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.


Advanced Ingredient Data


Raw Label Data

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