FDA Label for Alcaftadine

Drug Facts

Active ingredient
Alcaftadine 0.25%

Purpose

Antihistamine

Use

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

Warnings

For external use only

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 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 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.

If swallowed, get medical help or contact a Poison Control Center right away.

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
    
    

Other Information

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

Inactive Ingredients

benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, water for injection, sodium chloride, sodium hydroxide and/or hydrochloric acid

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

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) - alcaftadine fig1

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) - alcaftadine fig2

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 - alcaftadine fig3