DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Olopatadine (7 mg)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Hydrochloric Acid Hydroxypropyl .gamma.-cyclodextrin Hypromellose 2910 (4000 Mpa.s) Mannitol Polyethylene Glycol 400 Povidone K30 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2026-01-06

Medication Information

Purpose

Antihistamine

Description

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

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
- do not use more than 1 drop in each eye per day
- if using other ophthalmic products while using this product, wait at least 5minutes 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

Questions?

call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)

Active Ingredient

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

Other Information

• only for use in the eye

• store between 2° - 25°C (36° - 77°F)

Inactive Ingredients

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.

Principal Display Panel

Carton Label:

EXTRA STRENGTH

NDC 68083-398-01

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

FULL

24

HOUR

Works in Minutes

2.5 mL (0.085 fl oz)

STERILE

Bottle Label:

NDC 68083-398-01

EXTRA STRENGTH

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

EYE ALLERGY ITCH RELIEF

STERILE

2.5 mL (0.085 fl oz)

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:

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.

Structured Label Content

Use (USE)

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

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

adults and children 2 years of age and older:
- put 1 drop in the affected eye(s) once daily
- do not use more than 1 drop in each eye per day
- if using other ophthalmic products while using this product, wait at least 5minutes 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

Questions? (QUESTIONS?)

call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)

Active Ingredient (ACTIVE INGREDIENT)

Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)

Other Information (OTHER INFORMATION)

• only for use in the eye

• store between 2° - 25°C (36° - 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label:

EXTRA STRENGTH

NDC 68083-398-01

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

Eye Allergy Itch Relief

FULL

24

HOUR

Works in Minutes

2.5 mL (0.085 fl oz)

STERILE

Bottle Label:

NDC 68083-398-01

EXTRA STRENGTH

Olopatadine

Hydrochloride

Ophthalmic

Solution, USP

0.7%

Antihistamine

ONCE DAILY RELIEF

EYE ALLERGY ITCH RELIEF

STERILE

2.5 mL (0.085 fl oz)

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:

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.

Advanced Ingredient Data

[{"name": "OLOPATADINE", "unii": "D27V6190PM", "classCode": "ACTIM", "strengthNumerator": "7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL .GAMMA.-CYCLODEXTRIN", "unii": "P6BYU725IU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (4000 MPA.S)", "unii": "RN3152OP35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "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)

{"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 do not use more than 1 drop in each eye per day 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", "QUESTIONS?": "call 866-770-7144 (Monday – Friday 9:00 AM to 6:00 PM EST)", "ACTIVE INGREDIENT": "Olopatadine (0.7%)............(equivalent to olopatadine hydrochloride 0.776%)", "OTHER INFORMATION": "• only for use in the eye • store between 2° - 25°C (36° - 77°F)", "INACTIVE INGREDIENTS": "benzalkonium chloride 0.015% (preservative), boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropyl-gamma-cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water.", "PRINCIPAL DISPLAY PANEL": "Carton Label: EXTRA STRENGTH NDC 68083- 398 -01 Olopatadine Hydrochloride Ophthalmic Solution, USP 0.7% Antihistamine ONCE DAILY RELIEF Eye Allergy Itch Relief FULL 24 HOUR Works in Minutes 2.5 mL (0.085 fl oz) STERILE Bottle Label: NDC 68083- 398 -01 EXTRA STRENGTH Olopatadine Hydrochloride Ophthalmic Solution, USP 0.7% Antihistamine ONCE DAILY RELIEF EYE ALLERGY ITCH RELIEF STERILE 2.5 mL (0.085 fl oz)", "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: 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information