Active Ingredient
Alcaftadine 0.25%
Alcaftadine Solution/ Drops
FDA Label NDC 68083-649
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gland Pharma Limited for the product Alcaftadine (NDC 68083-649). 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 active ingredient, 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 that 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 at 15° to 25°C (59° to 77°F)
Inactive Ingredients
benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, water for injection
Questions Or Comments?
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Package Label-Principal Display Panel
Container Label - 0.25% (3 mL)
NDC-68083-649-01
Alcaftadine
Ophthalmic Solution
0.25%
Antihistamine Eye Drops
0.10 fl oz (3 mL) Sterile
Alcaftadine-spl-container-label (Alcaftadine Spl Container Label)
Container Carton - 0.25% (3 mL)
ORIGINAL PRESCRIPTION STRENGTH
NDC-68083-649-01 3 mL
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
40 DAY SUPPLY
Sterile 0.10 fl oz (3 mL)
Alcaftadine-spl-carton-label-mono-pack (Alcaftadine Spl Carton Label Mono Pack)
Container Carton - 0.25% (3 mL) - Twin Pack
ORIGINAL PRESCRIPTION STRENGTH
TWIN PACK
NDC-68083-649-02 3 mL
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
80 DAY SUPPLY
Sterile Two 3 mL bottles (0.10 fl oz each)
Alcaftadine-spl-carton-label-twin-pack (Alcaftadine Spl Carton Label Twin Pack) 
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