a3475f8c-c780-43c0-b22f-08a0ce5608fd

SPL v2
SPL
SPL Set ID a3475f8c-c780-43c0-b22f-08a0ce5608fd
Route
ophthalmic
Published
Effective Date 2026-01-07
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
olopatadine (7 mg)
Inactive Ingredients
benzalkonium chloride boric acid hydrochloric acid hydroxypropyl .gamma.-cyclodextrin hypromellose 2910 (4000 mpa.s) mannitol polyethylene glycol 400 povidone k30 sodium hydroxide water

Identifiers & Packaging

Marketing Status
anda active Since 2026-01-06

Purpose

Antihistamine

Description

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)


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 eye(s) once daily
    • do not use more than 1 drop in each eye per day
    • if using other ophthalmic products while using this product, wait at least 5minutes 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° - 25°C (36° - 77°F)

Inactive Ingredients

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.

Description

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

Principal Display Panel

Carton Label:

EXTRA STRENGTH

NDC 68083-398-01

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

FULL

24

HOUR

Works in Minutes

2.5 mL (0.085 fl oz)

STERILE 







Bottle Label:

NDC 68083-398-01

EXTRA STRENGTH

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF


EYE ALLERGY ITCH RELIEF

STERILE

2.5 mL (0.085 fl oz)







Questions?

call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)

Use

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

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

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 A 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 eye(s) once daily
    • do not use more than 1 drop in each eye per day
    • if using other ophthalmic products while using this product, wait at least 5minutes 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° - 25°C (36° - 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label:

EXTRA STRENGTH

NDC 68083-398-01

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

FULL

24

HOUR

Works in Minutes

2.5 mL (0.085 fl oz)

STERILE 







Bottle Label:

NDC 68083-398-01

EXTRA STRENGTH

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF


EYE ALLERGY ITCH RELIEF

STERILE

2.5 mL (0.085 fl oz)







Questions? (QUESTIONS?)

call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)

Use (USE)

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 (ACTIVE INGREDIENT)

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

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 A Doctor If (STOP USE AND ASK A 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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