drug facts

drug facts
SPL v1
SPL
SPL Set ID 3e86783f-0001-625f-e063-6294a90acd20
Route
ophthalmic
Published
Effective Date 2025-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
anda active Since 2025-09-15

Description

Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Directions
  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(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 2°C to 25°C (36°F to 77°F)
Inactive Ingredients

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

Description

Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

Principal Display Panel

Original Prescription Strength



ONCE DAILY RELIEF



Olopatadine hydrochloride ophthalmic solution 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE

2.5 mL



NDC: 68001-674-92

Label

Original Prescription Strength



ONCE DAILY RELIEF



Olopatadine hydrochloride ophthalmic solution 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE

2.5 mL



NDC: 68001-674-92

Carton

Questions?

In the U.S., call toll free weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Manufactured by: SamChunDang Pharm. Co., Ltd.

71 Jeyakgongdan-2Gil; Hyangnam-eup, Hwaseong,

Gyeonggi 18622, Korea, South (KOR)

For BluePoint Laboratories

Product of Spain

Rev 08/25

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifyou experience:

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

Section 55105-1

Active Ingredients

  • Purpose

Olopatadine 0.2%

(equivalent to olopatadine hydrochloride 0.222%)

Antihistamine

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Indications and Usage (34067-9)

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

Directions
  • adults and children 2 years of age and older:
    • put 1 drop in the affected eye(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 2°C to 25°C (36°F to 77°F)
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Original Prescription Strength



ONCE DAILY RELIEF



Olopatadine hydrochloride ophthalmic solution 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE

2.5 mL



NDC: 68001-674-92

Label

Original Prescription Strength



ONCE DAILY RELIEF



Olopatadine hydrochloride ophthalmic solution 0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE

2.5 mL



NDC: 68001-674-92

Carton

Questions?

In the U.S., call toll free weekdays 9 AM to 6 PM EST at 1 (888) 721-7115.

Manufactured by: SamChunDang Pharm. Co., Ltd.

71 Jeyakgongdan-2Gil; Hyangnam-eup, Hwaseong,

Gyeonggi 18622, Korea, South (KOR)

For BluePoint Laboratories

Product of Spain

Rev 08/25

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifyou experience:

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

Section 55105-1 (55105-1)

Active Ingredients

  • Purpose

Olopatadine 0.2%

(equivalent to olopatadine hydrochloride 0.222%)

Antihistamine

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

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


Advanced Ingredient Data


Raw Label Data

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