5f9e93e7-ff12-484d-add8-4f834193c1c6

SPL v3
SPL
SPL Set ID 5f9e93e7-ff12-484d-add8-4f834193c1c6
Route
ophthalmic
Published
Effective Date 2020-10-09
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 4° to 25°C (39° 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:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648



Made in India

Code: TS/DRUGS/13/2010

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)

PrimaryHealth                               NDC 58602-013-39

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

STERILE                                     2.5 mL (0.085 FL OZ)

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

                                                      NDC 58602-013-39

                                                            PrimaryHealth

                              *Compare to the Active Ingredient

                                    in Pataday® Once Daily Relief



NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     ONCE

• Grass • Ragweed                          DAILY

                                                     STERILE

                                  2.5 mL (0.085 FL OZ)

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

Twin Pack

                                                      NDC 58602-013-41

PrimaryHealth 

                              *Compare to the Active Ingredient

                                     in Pataday® Once Daily Relief



NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                      ONCE

• Grass • Ragweed                          DAILY

                                                     STERILE

                                     Two 2.5 mL Bottles

(0.085 FL OZ EACH)


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 4° to 25°C (39° 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:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648



Made in India

Code: TS/DRUGS/13/2010

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))

PrimaryHealth                               NDC 58602-013-39

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

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 58602-013-39

                                                            PrimaryHealth

                              *Compare to the Active Ingredient

                                    in Pataday® Once Daily Relief



NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                     ONCE

• Grass • Ragweed                          DAILY

                                                     STERILE

                                  2.5 mL (0.085 FL OZ)

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

Twin Pack

                                                      NDC 58602-013-41

PrimaryHealth 

                              *Compare to the Active Ingredient

                                     in Pataday® Once Daily Relief



NOW AVAILABLE without a prescription

Olopatadine Hydrochloride

Ophthalmic Solution, USP

0.2%

Antihistamine

Eye Allergy Itch Relief

Works in Minutes

Relief from Allergens:

• Pet Dander • Pollen                      ONCE

• Grass • Ragweed                          DAILY

                                                     STERILE

                                     Two 2.5 mL Bottles

(0.085 FL OZ EACH)


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