480 - Eye Relief

SPL v2

SPL

SPL Set ID fdb808ef-9d5f-4bc3-86e7-f519b5c75a46

Route

OPHTHALMIC

Published

Effective Date 2025-05-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Olopatadine (1 mg)

Inactive Ingredients

Benzalkonium Chloride Hydrochloric Acid Sodium Hydroxide Sodium Phosphate Dibasic Dihydrate Sodium Chloride Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2025-05-05

Description

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

Purpose

Antihistamine and redness reliever

Medication Information

Purpose

Antihistamine and redness reliever

Description

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

Use(s)

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Directions

adults and children 2 years and older:
- put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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

Other Information

Only for use in the eye
Store between 4ºC to 25ºC (39ºF to 77ºF)

Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

Inactive Ingredients

benzalkonium chloride 0.01%, hydrochloric acid/sodium hydroxide (adjust pH), sodium phosphate

dibasic (anhydrous), sodium chloride and water for injection.

Do Not Use If You Have

If solution changes color or becomes cloudy
If you are sensitive to any ingredient in this product
To treat contact lens related irritation

Principal Display Panel

Eye Relief, Label

Eye Relief, Carton

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

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(s)

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Purpose

Antihistamine and redness reliever

Warnings

For external use only

Directions

adults and children 2 years and older:
- put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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

Other Information (Other information)

Only for use in the eye
Store between 4ºC to 25ºC (39ºF to 77ºF)

Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, hydrochloric acid/sodium hydroxide (adjust pH), sodium phosphate

dibasic (anhydrous), sodium chloride and water for injection.

Do Not Use If You Have (Do not use if you have)

If solution changes color or becomes cloudy
If you are sensitive to any ingredient in this product
To treat contact lens related irritation

Principal Display Panel

Eye Relief, Label

Eye Relief, Carton

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)

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": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE DIBASIC DIHYDRATE", "unii": "94255I6E2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.", "Purpose": "Antihistamine and redness reliever", "Warnings": "For external use only", "Directions": "adults and children 2 years and older: put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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", "Other information": "Only for use in the eye Store between 4ºC to 25ºC (39ºF to 77ºF)", "Questions/Comments": "Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)", "Active ingredient(s)": "Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)", "Inactive ingredients": "benzalkonium chloride 0.01%, hydrochloric acid/sodium hydroxide (adjust pH), sodium phosphate dibasic (anhydrous), sodium chloride and water for injection.", "Do not use if you have": "If solution changes color or becomes cloudy If you are sensitive to any ingredient in this product To treat contact lens related irritation", "Principal Display Panel": "Eye Relief, Label Eye Relief, Carton", "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": "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. "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:39.921401 · Updated: 2026-03-14T23:09:34.496634