FDA Label for Alcaftadine
View Indications, Usage & Precautions
Alcaftadine Product Label
The following document was submitted to the FDA by the labeler of this product Gland Pharma Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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
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)
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)
* Please review the disclaimer below.