NDC 72695-0006 Medikoii Bio-active Vital Shot Ampoule Starter Kit

Glycerin

NDC Product Code 72695-0006

NDC CODE: 72695-0006

Proprietary Name: Medikoii Bio-active Vital Shot Ampoule Starter Kit 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

  • 72695 - Theranotics Co.,ltd.
    • 72695-0006 - Medikoii Bio-active Vital Shot Ampoule Starter Kit

NDC 72695-0006-2

Package Description: 2 BOTTLE, WITH APPLICATOR in 1 CARTON > 3 mL in 1 BOTTLE, WITH APPLICATOR (72695-0006-1)

NDC Product Information

Medikoii Bio-active Vital Shot Ampoule Starter Kit with NDC 72695-0006 is a a human over the counter drug product labeled by Theranotics Co.,ltd.. The generic name of Medikoii Bio-active Vital Shot Ampoule Starter Kit is glycerin. The product's dosage form is gel and is administered via topical form.

Labeler Name: Theranotics Co.,ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Medikoii Bio-active Vital Shot Ampoule Starter Kit 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 1.222 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)
  • ADENOSINE (UNII: K72T3FS567)
  • NIACINAMIDE (UNII: 25X51I8RD4)

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: Theranotics Co.,ltd.
Labeler Code: 72695
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-10-2020 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.

Medikoii Bio-active Vital Shot Ampoule Starter Kit Product Label Images

Medikoii Bio-active Vital Shot Ampoule Starter Kit 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

Glycerin

Inactive Ingredient

Water, Niacinamide, Adenosine, etc.

Otc - Purpose

Skin protectant

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Apply proper amount to the skin.

Warnings

1. Do not use in the following cases(Eczema and scalp wounds)













2.Side Effects













1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor













3.General Precautions













1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately













2)This product is for exeternal use only. Do not use for internal use













4.Storage and handling precautions













1)If possible, avoid direct sunlight and store in cool and area of low humidity













2)In order to maintain the quality of the product and avoid misuse













3)Avoid placing the product near fire and store out in reach of children

Dosage & Administration

For external use only

* Please review the disclaimer below.