NDC 70694-0008 Medi Hydro Dp Stem C Ampoule

Glycerin

NDC Product Code 70694-0008

NDC Product Information

Medi Hydro Dp Stem C Ampoule with NDC 70694-0008 is a a human over the counter drug product labeled by Inc Mbg. The generic name of Medi Hydro Dp Stem C Ampoule is glycerin. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Inc Mbg

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.


Medi Hydro Dp Stem C Ampoule 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 10 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.

Product Labeler Information

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

Labeler Name: Inc Mbg
Labeler Code: 70694
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: 01-24-2019 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.

Medi Hydro Dp Stem C Ampoule Product Label Images

Medi Hydro Dp Stem C Ampoule 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

Indications & Usage

Open the lid, press the lid to fill the dropper and apply evenly 3-4 drops to the desired parts, gently tap with the fingers to allow it to absorb

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

For external use only

Warnings

Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.

a) If redness, Swelling, Itchiness, Irritation occurred during using.

b) If the above symptoms started to occur when exposed to direct sunlight.

Do not use on skins with wounds, eczema or dermatitis.
Storage instructions

a) Always close the lid after finish using.

b) Store in a safe place away and out of reach of children.

c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure.

Otc - Purpose

Ampoule with human stem-cell-culture fluids and EGF that helps improving skin texture

Inactive Ingredient

Water, butylene glycol, hyaluronic acid, alcohol, etc.

Otc - Active Ingredient

Glycerin

* Please review the disclaimer below.

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