NDC 72945-0003 Pearsys

Sodium Hyaluronate

NDC Product Code 72945-0003

NDC Product Information

Pearsys with NDC 72945-0003 is a a human over the counter drug product labeled by J World. The generic name of Pearsys is sodium hyaluronate. The product's dosage form is patch and is administered via topical form.

Labeler Name: J World

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Pearsys 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.

  • HYALURONATE SODIUM 6.14 g/100g

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.

  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: J World
Labeler Code: 72945
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: 07-21-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pearsys Product Label Images

Pearsys 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

Inactive Ingredient

Water

Caprylyl glycol

Acetyl hexapeptide-8
Cellulose gum

Lactose

Glycerin
Calendula officinalis flower extract

1,2-Hexanediol
Glycyrrhiza uralensis (licorice) root extract

Propanediol

Ethylhexyl glycerin

Madecassoside

Otc - Purpose

DMS (Dissolving Micro Structure) Technology Microchip gives minute skin stimulation to help skin concentrate and absorb active ingredients

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Spread water soluble cosmetics all over your face before usingopen one sterilized micro chip roller for usepress the left pushbutton of the dedicated roller handle to insert a micro chip rollergently rolls massages along the fact surface from inside to outsideuse only until you feel no stimulation from the micro chipafter using, apply cosmetics evenly across faceafter using, press the roller handle depressor to discard the micro chip roller (the micro chip roller is disposable)dedicated roller handle keeps it clean with a continous use product(this product is recommended to use one every 2 to 3 days)

Warnings

Use it for your own use only.For external use only.Discontinue use if adverse reaction occurs.Contact a physician if symptoms persist.Store at room temperature.Do not reuse it as a disposable product.Please use it immediately after opening.

Dosage & Administration

For topical use only

* Please review the disclaimer below.

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