Alcaftadine Ophthalmic Solution 0.25%

Alcaftadine Ophthalmic Solution 0.25%
SPL v3
SPL
SPL Set ID b94e071d-421d-48ec-a4ea-254aa8af19ff
Route
OPHTHALMIC
Published
Effective Date 2024-03-06
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Alcaftadine (2.5 mg)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Hydrochloric Acid Sodium Phosphate, Monobasic Sodium Chloride Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-03-01

Description

Alcaftadine 0.25%

Purpose

Antihistamine


Medication Information

Purpose


Antihistamine

Description

Alcaftadine 0.25%

Use


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

Warnings


For external use only

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
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

Active Ingredient


Alcaftadine 0.25%

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?

866-770-7144

(Monday – Friday 9:00 AM to 6:00 PM EST)



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.

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)


Structured Label Content

Use


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

Purpose


Antihistamine

Warnings


For external use only

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
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

Active Ingredient (Active ingredient)


Alcaftadine 0.25%

Other Information (Other information)
  • only for use in the eye
  • store at 15° to 25°C (59° to 77°F)
Inactive Ingredients (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? (Questions or comments?)

866-770-7144

(Monday – Friday 9:00 AM to 6:00 PM EST)



When Using This Product (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 (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 (Keep out of reach of children)


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

Package Label Principal Display Panel (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)


Advanced Ingredient Data


Raw Label Data

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