Active Ingredient
Sodium Hyaluronate 0.1%
Sodium Hyaluronate Eye Drops Liquid
FDA Label NDC 87298-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Hechuang Commercial Service Co.,ltd. for the product Sodium Hyaluronate Eye Drops (NDC 87298-037). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, inactive ingredients, indications & usage, dosage & administration, warnings, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eye lubricant
Inactive Ingredients
Water、sodium chloride、Pyridoxine、Cyanocobalamin
Indications & Usage
Used for dry eye syndrome
Relieve dry eye symptoms
•The temporary relief of burning and irritation due to dryness of the eye.
•The temporary relief of discomfort due to minor irritations of the eye or exposure to wind or sun.
•Use as a protectant against further irritation or to relieve dryness of the eye.
•Use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Dosage & Administration
Directions
To open, Twist and pull tab to remove.
•Instill 1 or 2 drops as needed.
•If used for dryness and discomfort associated with LASIK, follow your eye doctor's instructions.
Warnings
•For external use only.
•To avoid contamination, do not touch tip of container to any surface.
•Use within 30 days after opening. Maintain good hygiene during use and reseal tightly after each use.
•If solution changes color, do not use.
Stop Use And Ask A Doctor
Stop use and ask a doctor.
If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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.
Other Information
•Use only if container is intact.
•Use before expiration date markedon container.
•Store at 59°-86°F (15°-30°C).
•Protect from sunlight.
•Retain this carton for future reference.
Rems Administrative Information
Distributed by:Mitsui Pharmaceutical Co., Ltd.
Package Label.Principal Display Panel
Principal Display Panel (Label)
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