12d48ef6-ccf1-4bc3-8469-0061bb083f7c

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
Purpose

Antihistamine

Description

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

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, 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° 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

Description

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

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
Drug Facts

Active ingredient

 Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

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

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, 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° 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

Questions?

✆ 1-855-274-4122



distributed by:

AllWell Health, Inc.

Princeton, NJ 08540

getallwell.com



Made in India

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
Drug Facts

Active ingredient

 Olopatadine (0.2%)

(equivalent to olopatadine hydrochloride, USP 0.222%)

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