NDC 82357-1101 Lubricant Eye Drops

Sodium Hyaluronate

NDC Product Code 82357-1101

NDC 82357-1101-2

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 3 mL in 1 BOTTLE, PLASTIC (82357-1101-1)

NDC Product Information

Lubricant Eye Drops with NDC 82357-1101 is a a human over the counter drug product labeled by Mfb Global Llc. The generic name of Lubricant Eye Drops is sodium hyaluronate. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lubricant Eye Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mfb Global Llc
Labeler Code: 82357
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-05-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lubricant Eye Drops Product Label Images

Lubricant Eye Drops Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Sodium Hyaluronate 1%

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 1Purified 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.