ALCAFTADINE solution/ drops

Alcaftadine by

Drug Labeling and Warnings

Alcaftadine by is a Otc medication manufactured, distributed, or labeled by Gland Pharma Limited, GLAND PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

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

   

  

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)

INGREDIENTS AND APPEARANCE

ALCAFTADINE 
alcaftadine solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68083-649
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCAFTADINE (UNII: 7Z8O94ECSX) (ALCAFTADINE - UNII:7Z8O94ECSX)	ALCAFTADINE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68083-649-01	1 in 1 CARTON	03/01/2024
1		3 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC: 68083-649-02	2 in 1 CARTON	03/01/2024
2		3 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209706	03/01/2024

Labeler - Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Business Operations
GLAND PHARMA LIMITED		918601238	ANALYSIS(68083-649) , LABEL(68083-649) , MANUFACTURE(68083-649) , PACK(68083-649)