ALCAFTADINE solution/ drops

Alcaftadine by

Drug Labeling and Warnings

Alcaftadine by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Eugia Pharma Specialities Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 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 between 15° to 25°C (59° to 77°F)

Inactive ingredients

benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, water for injection, sodium chloride, sodium hydroxide and/or hydrochloric acid

Questions?

✆1-855-274-4122
(Monday – Friday 8:30 AM to 5:00 PM EST).

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India
 
Revised: May 2023

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25 % (5 mL Container Label)

AUROHEALTH                NDC 58602-605-40
Alcaftadine
Ophthalmic Solution
0.25%

Antihistamine Eye Drops
STERILE                                0.17 fl oz (5 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton)

AUROHEALTH                    NDC 58602-605-40
*Compare to the Active Ingredient in
Lastacaft® Once Daily Relief

Original Prescription Strength
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

60 DAY SUPPLY
Sterile                             0.17 fl oz (5 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.25% (5 mL Container-Carton) Twin Pack

AUROHEALTH                NDC 58602-605-42
*Compare to the Active Ingredient in
Lastacaft® Once Daily Relief
TWIN PACK
Original Prescription Strength
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
120 DAY SUPPLY
Sterile                     Two 5 mL bottles (0.17 fl oz each)

INGREDIENTS AND APPEARANCE

ALCAFTADINE 
alcaftadine solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-605
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: 58602-605-40	1 in 1 CARTON	06/23/2023
1		5 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 58602-605-42	2 in 1 CARTON	06/23/2023
2		5 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210659	06/23/2023

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Eugia Pharma Specialities Limited		650498244	ANALYSIS(58602-605) , MANUFACTURE(58602-605) , PACK(58602-605)