Otc - Active Ingredient
Sodium Hyaluronate 1%
Lubricant Eye Drops
FDA Label NDC 82357-1101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mfb Global Llc for the product Lubricant Eye Drops (NDC 82357-1101). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - do not use, user safety warnings, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Lubricant
Dosage & Administration
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.
For use as a protectant against further irritation or to relieve dryness of the eye.
For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Relieves redness of the eye due to minor eye irritations.
Warnings
For external use only
Otc - Do Not Use
if solution changes color or becomes cloudy.
User Safety Warnings
if you have narrow angle glaucoma.
Otc - When Using
To avoid contamination, do not touch tip of container to any surface. ■ Replace cap after using. ■ Overuse of this product may produce increased redness of the eye. ■ Pupils may become enlarged temporarily.
Otc - Ask Doctor
if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the symptom worsens or persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help of contact a Poison Control Center right away.
Indications & Usage
Instill 1 or 2 drops in the affected eye(s) as needed up to four times daily.
Other Safety Information
Keep refrigerated. Store at 4-10℃(39-50℉). ■ Tamper Evident. Do not use if ring around the bottom of bottle cap is broken or missingminor eye irritations.
Inactive Ingredient
Polyquaternium 1
Purified Water.
Patient Counseling Information
1-646-339-5789
Other
Manufacturer: DrSignal BioTechnology Co., Ltd. (No. 2-1, Ln. 181, Sec. 2, Jiuzong Rd., Neihu Dist., Taipei City 114, Taiwan)
Distributor: MFB Global LLC
(136-17 39th Ave Suite 301, Flushing, NY 11354, USA) Tel: 1-646-339-5789
Made in Taiwan
Description
product information
* Please review the disclaimer below.
