56d56cb8-b04c-5f48-b0c3-5639a79fd2c5

SPL v1
SPL
SPL Set ID 56d56cb8-b04c-5f48-b0c3-5639a79fd2c5
Route
ophthalmic
Published
Effective Date 2026-01-15
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 2026-01-15

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 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° to 25°C (36° to 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

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

2.5 mL (0.085 fl oz)

Sterile 







Bottle Label:



EXTRA STRENGTH

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

2.5 mL (0.085 fl oz)

Sterile 



Questions?

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Distributed by:

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

Made in India

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 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(1-800-222-1222).


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 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° to 25°C (36° to 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

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

2.5 mL (0.085 fl oz)

Sterile 







Bottle Label:



EXTRA STRENGTH

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

2.5 mL (0.085 fl oz)

Sterile 



Questions? (QUESTIONS?)

call toll-free weekdays 8 AM to 8 PM EST at 1-888-375-3784

Distributed by:

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

Made in India

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 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(1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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