NDC 71619-300 Cellstory Plus Cell Cleanser

Glycerin

NDC Product Code 71619-300

NDC CODE: 71619-300

Proprietary Name: Cellstory Plus Cell Cleanser What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Glycerin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 71619 - Beauren Korea Inc.

NDC 71619-300-02

Package Description: 60 POUCH in 1 CARTON > 1 mL in 1 POUCH (71619-300-01)

NDC Product Information

Cellstory Plus Cell Cleanser with NDC 71619-300 is a a human over the counter drug product labeled by Beauren Korea Inc.. The generic name of Cellstory Plus Cell Cleanser is glycerin. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Beauren Korea Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Cellstory Plus Cell Cleanser 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.

  • GLYCERIN 5 g/100mL

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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.
  • 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: Beauren Korea Inc.
Labeler Code: 71619
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: 02-22-2020 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: 12-31-2021 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.

Cellstory Plus Cell Cleanser Product Label Images

Cellstory Plus Cell Cleanser 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

Active Ingredient

Glycerin

Inactive Ingredient

Water, Sodium Lauryl Sulfate, Potassium CocoylGlycinate, Sodium Cocoyl Apple Amino Acids, Disodium Lauroamphodiacetate, DecylGlucoside, Panthenol, Hexylene Glycol, 1,2-Hexanediol, Butylene Glycol, Caprylyl Glycol, Allantoin, Dimethyl Sulfone, Citric Acid, IlliciumVerum (Anise) Fruit Extract, Disodium EDTA, CentellaAsiatica Extract, PunicaGranatum Fruit Extract, FicusCarica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Glycine, Serine, Glutamic Acid, Brassica OleraceaItalica (Broccoli) Extract, Medicago Sativa (Alfalfa) Extract, Brassica OleraceaCapitata (Cabbage) Leaf Extract, TriticumVulgare (Wheat) Germ Extract, Pentylene Glycol, Aspartic Acid, Leucine, Brassica Campestris (Rapeseed) Extract, RaphanusSativus (Radish) Seed Extract, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Histidine, Sodium Phosphate, Tryptophan, Asparagine, Cysteine, Glutamine, Methionine, sh-Oligopeptide-1, sh-Oligopeptide-2, sh-Polypeptide-1

Purpose

Remove waste and makeup on the skin surface without stimulation.

Warnings

For external use onlyUse each product (1ml) only once. Use immediately after opening the product.Avoid contact with eyes.Discontinue use if signs of irritationor rashes appear.Do not use on damaged or broken skin.

Keep Out Of Reach Of Children

Keep Out of Reach of ChildrenStore away from hot or cold places and direct sunlight.

Uses

Uses: Helps skin brightening and anti-wrinkle.

Directions

Take Cell Cleanser onto your wet hands and make foams.After rubbing your skin with the cleansing foam, remove it with a disposable sponge or damp sponge.Topical use only

* Please review the disclaimer below.