SPL v1
SPL
SPL Set ID 12d48ef6-ccf1-4bc3-8469-0061bb083f7c
Route
OPHTHALMIC
Published
Effective Date 2021-03-01
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Olopatadine (2 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Edetate Disodium Hydrochloric Acid Sodium Hydroxide Povidone, Unspecified Sodium Chloride Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-07-15
Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Active ingredient Olopatadine (0.2%) (equivalent to olopatadine hydrochloride, USP 0.222%)

Use

temporarily relieves itchy 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) 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

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
Drug Facts

Active ingredient

 Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆ 1-855-274-4122



distributed by:

AllWell Health, Inc.

Princeton, NJ 08540

getallwell.com



Made in India

Other Information
  • only for use in the eye
  • store between 2° to 25°C (36° to 77°F)
Inactive Ingredients

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

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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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
Package Label Principal Display Panel 0.2% (2.5 Ml Container)

allwell        ONCE DAILY

eye allergy itch relief

olopatadine hydrochloride

ophthalmic solution USP, 0.2%

antihistamine

STERILE           2.5 mL (0.085 FL OZ)



Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton)

                                         NDC 80539-001-39

allwell

 eye allergy

 itch relief

olopatadine hydrochloride

ophthalmic solution USP, 0.2%

original prescription strength

antihistamine

- works in minutes

relief from allergens:

- pollen - pet dander        ONCE

- grass  - ragweed            DAILY

2.5 mL (0.085 FL OZ)    STERILE

Structured Label Content

Use

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

Purpose

Antihistamine

Warnings

For external use only

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

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
Drug Facts

Active ingredient

 Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

Questions?

✆ 1-855-274-4122



distributed by:

AllWell Health, Inc.

Princeton, NJ 08540

getallwell.com



Made in India

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

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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Ask A Doctor If You Experience: (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
Package Label Principal Display Panel 0.2% (2.5 Ml Container) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container))

allwell        ONCE DAILY

eye allergy itch relief

olopatadine hydrochloride

ophthalmic solution USP, 0.2%

antihistamine

STERILE           2.5 mL (0.085 FL OZ)



Package Label Principal Display Panel 0.2% (2.5 Ml Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton))

                                         NDC 80539-001-39

allwell

 eye allergy

 itch relief

olopatadine hydrochloride

ophthalmic solution USP, 0.2%

original prescription strength

antihistamine

- works in minutes

relief from allergens:

- pollen - pet dander        ONCE

- grass  - ragweed            DAILY

2.5 mL (0.085 FL OZ)    STERILE

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:26.377234 · Updated: 2026-03-14T22:59:24.470306