ALCAFTADINE - alcaftadine solution/ drops 
Gland Pharma Limited

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Alcaftadine Ophthalmic Solution 0.25%

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

Other information

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)


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


  

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

 

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 
alcaftadine solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68083-649
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCAFTADINE (UNII: 7Z8O94ECSX) (ALCAFTADINE - UNII:7Z8O94ECSX) ALCAFTADINE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68083-649-011 in 1 CARTON03/01/2024
13 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:68083-649-022 in 1 CARTON03/01/2024
23 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20970603/01/2024
Labeler - Gland Pharma Limited (918601238)
Establishment
NameAddressID/FEIBusiness Operations
GLAND PHARMA LIMITED918601238ANALYSIS(68083-649) , LABEL(68083-649) , MANUFACTURE(68083-649) , PACK(68083-649)

Revised: 3/2024
Document Id: 8c937f90-5ae8-49e9-808d-f3dbd9da1882
Set id: b94e071d-421d-48ec-a4ea-254aa8af19ff
Version: 3
Effective Time: 20240305
 
Gland Pharma Limited