Alcaftadine ALCAFTADINE AUROHEALTH LLC FDA Approved Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
FunFoxMeds bottle
Substance Alcaftadine
Route
OPHTHALMIC
Applications
ANDA210659

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient Alcaftadine 0.25%
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.005% edetate disodium monobasic sodium phosphate water for injection sodium chloride sodium hydroxide and/or hydrochloric acid
Strengths
0.25 %
Quantities
5 ml 10 ml
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOTTLE
UNII
7Z8O94ECSX
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container Label) AUROHEALTH NDC 58602-605-40 Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops STERILE 0.17 fl oz (5 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton) AUROHEALTH NDC 58602-605-40 *Compare to the Active Ingredient in Lastacaft® Once Daily Relief Original Prescription Strength Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: ✓ Pet Dander ✓ Pollen ✓ Grass ✓ Ragweed 60 DAY SUPPLY Sterile 0.17 fl oz (5 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (10 mL Container Carton); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton) Twin Pack AUROHEALTH NDC 58602-605-42 *Compare to the Active Ingredient in Lastacaft® Once Daily Relief TWIN PACK Original Prescription Strength Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: ✓ Pet Dander ✓ Pollen ✓ Grass ✓ Ragweed 120 DAY SUPPLY Sterile Two 5 mL bottles (0.17 fl oz each) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container Carton) Twin Pack

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container Label) AUROHEALTH NDC 58602-605-40 Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops STERILE 0.17 fl oz (5 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton) AUROHEALTH NDC 58602-605-40 *Compare to the Active Ingredient in Lastacaft® Once Daily Relief Original Prescription Strength Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: ✓ Pet Dander ✓ Pollen ✓ Grass ✓ Ragweed 60 DAY SUPPLY Sterile 0.17 fl oz (5 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (10 mL Container Carton)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton) Twin Pack AUROHEALTH NDC 58602-605-42 *Compare to the Active Ingredient in Lastacaft® Once Daily Relief TWIN PACK Original Prescription Strength Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: ✓ Pet Dander ✓ Pollen ✓ Grass ✓ Ragweed 120 DAY SUPPLY Sterile Two 5 mL bottles (0.17 fl oz each) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container Carton) Twin Pack

Overview

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

Indications & Usage

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

Dosage & Administration

Directions adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily, 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

Warnings & Precautions
Warnings For external use only
Purpose

Purpose Antihistamine

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

When Using

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 & Ask a Doctor

Stop use and ask a doctor if you experience any of the following: 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.

Storage & Handling

Other information only for use in the eye store between 15° to 25°C (59° to 77°F)

Questions

Questions? ✆1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST). Distributed by: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648 Made in India Revised: May 2023


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