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

Purpose

Antihistamine and redness reliever

Description

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


Medication Information

Warnings

For external use only

Purpose

Antihistamine and redness reliever

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 

Other Information


▪ only for use in the eye 

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

Inactive Ingredients

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

Description

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

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

Questions?

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

Use(s)

temporarily relieves itchy and red 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 (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

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 and redness reliever

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 

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)

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

Questions?

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

Use(s) (USE(S))

temporarily relieves itchy and red 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 (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

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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