说明与适用边界
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spl product data elements
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE Olopatadine BENZALKONIUM CHLORIDE EDETATE DISODIUM HYDROCHLORIC ACID POVIDONE K30 SODIUM CHLORIDE SODIUM HYDROXIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS WATER
活性成分 / Active ingredient
Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
active ingredient table
<table cellpadding="0.4pt" cellspacing="0pt" width="95.98%"><col width="54%"/><col width="40%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Active Ingredients</content></content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption><content styleCode="bold"><content styleCode="italics">Purpose</content></content></item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>
用途 / Purpose
Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine
purpose table
<table cellpadding="0.4pt" cellspacing="0pt" width="95.98%"><col width="54%"/><col width="40%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Active Ingredients</content></content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption><content styleCode="bold"><content styleCode="italics">Purpose</content></content></item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>
适应证 / Indications and usage
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
警告 / Warnings
Warnings For external use only
禁用事项 / 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
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
停用事项 / Stop use
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
儿童安全 / 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.
用法用量原文 / Dosage and administration
Directions • adults and children 2 years of age and older: o put 1 drop in the affected eye(s) once daily, no more than once per day o if using other ophthalmic products while using this product, wait at least 5 minutes between each product o replace cap after each use • children under 2 years of age: consult a doctor
储存 / Storage and handling
Other information • only for use in the eye • store between 2°C to 25°C (36°F to 77°F)
辅料 / Inactive ingredients
Inactive ingredients benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection
questions
Questions? Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115. Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 Product of Spain 07/2025
package label principal display panel
PRINCIPAL DISPLAY PANEL NDC 72657-194-25 Olopatadine HCl Ophthalmic Solution 0.2% Antihistamine Once Daily STERILE 2.5 mL (0.085 FL OZ) NDC: 72657-194-25 Original Prescription Strength ONCE DAILY Olopatadine HCl Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief STERILE 2.5 mL (0.085 FL OZ) label carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20260127
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

