{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-03",
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{
"spl_product_data_elements": [
"Systane Ultra Polyethylene Glycol 400 and Propylene Glycol Polyethylene Glycol 400 Polyethylene Glycol 400 Propylene Glycol Propylene Glycol Aminomethylpropanol Boric Acid Guar Gum Polidronium Chloride Potassium Chloride Water Sodium Chloride Sorbitol Hydrochloric Acid Sodium Hydroxide Carton 300051246-1221"
],
"active_ingredient": [
"Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant",
"",
""
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun"
],
"warnings": [
"Warnings For external use only"
],
"do_not_use": [
"Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product"
],
"when_using": [
"When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use"
],
"stop_use": [
"Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists 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.",
""
],
"dosage_and_administration": [
"Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed"
],
"other_safety_information": [
"Other information store at room temperature"
],
"inactive_ingredient": [
"Inactive ingredients aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquarternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH."
],
"questions": [
"Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL Systane ® LUBRICANT EYE DROPS ULTRA HIGH PERFORMING DRY EYE RELIEF Fast-acting hydration and lasting relief Moisture rich formula #1 Doctor Recommended Brand 1 Alcon STERILE 10mL (1/3 FL OZ) SIDE PANEL: TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. U.S. Pat.: www.alconpatents.com Country Of Origin: Singapore Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops. From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. 300068356-0924 Systane ® LUBRICANT EYE DROPS ULTRA HIGH PERFORMING DRY EYE RELIEF Fast-acting hydration and lasting relief Moisture rich formula #1 Doctor Recommended Brand 1 Alcon STERILE 10mL (1/3 FL OZ) SIDE PANEL: TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. www.alconpatents.com Made in USA from domestic and imported materials. Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops. From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA. ACTUAL SIZE Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134 USA 1 Based on a survey of eye care professionals. Data on file. 300051246-1221"
],
"set_id": "0537c23a-15f7-be64-1231-a6c93468e9a8",
"id": "85a171a8-6208-4d82-8e8f-472b6c480866",
"effective_time": "20250730",
"version": "19",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"Systane Ultra"
],
"generic_name": [
"POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL"
],
"manufacturer_name": [
"Alcon Laboratories, Inc."
],
"product_ndc": [
"0065-1431"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"substance_name": [
"POLYETHYLENE GLYCOL 400",
"PROPYLENE GLYCOL"
],
"rxcui": [
"477589"
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"0065-1431-80",
"0065-1431-01",
"0065-1431-05",
"0065-1431-18",
"0065-1431-21",
"0065-1431-28",
"0065-1431-31",
"0065-1431-41"
],
"is_original_packager": [
true
],
"upc": [
"0300651431056"
],
"unii": [
"B697894SGQ",
"6DC9Q167V3"
]
}
}
]
}