Drug Facts
Active ingredient
Alcaftadine 0.25%
Alcaftadine Solution/ Drops
FDA Label NDC 58602-605
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Alcaftadine (NDC 58602-605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 Package Label-principal Display Panel-0.25 % (5 mL Container) (Alcaftadine Fig1)
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-Carton)
AUROHEALTH NDC 58602-605-40 Package Label-principal Display Panel-0.25% (10 mL Container Carton) (Alcaftadine Fig2)
*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% (5 Ml Container-Carton) Twin Pack
AUROHEALTH NDC 58602-605-42 Package Label-principal Display Panel-0.25% (5 mL Container Carton) Twin Pack (Alcaftadine Fig3)
*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) 
* Please review the disclaimer below.
