DailyMed - DailyMed Details

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 2023-06-23

Medication Information

Purpose

Antihistamine

Description

Active ingredient 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

Drug Facts

Active ingredient

Alcaftadine 0.25%

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

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

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.

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)

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

Drug Facts

Active ingredient

Alcaftadine 0.25%

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

Other Information (Other information)

only for use in the eye
store between 15° to 25°C (59° to 77°F)

Inactive Ingredients (Inactive ingredients)

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

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 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 0.25 % (5 Ml Container Label) (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) (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 (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)

Advanced Ingredient Data

[{"name": "ALCAFTADINE", "unii": "7Z8O94ECSX", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

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