NDC 70694-0014 Medi Hydro Dp Bb

Glycerin

NDC Product Code 70694-0014

NDC Product Information

Medi Hydro Dp Bb with NDC 70694-0014 is a a human over the counter drug product labeled by Inc Mbg. The generic name of Medi Hydro Dp Bb is glycerin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Inc Mbg

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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 Bb Active Ingredient(s)

Additional informationCallout TooltipWhat 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 4 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Bb Product Label Images

Medi Hydro Dp Bb 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

Apply enough amount on face by rubbing it outward along the skin texture, gently tap allowing 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

Softly covers dark and uneven complexion to create flawless skin.

Inactive Ingredient

Water, butylene glycol, niacinamide, etc.

Otc - Active Ingredient

Glycerin

* Please review the disclaimer below.

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70694-0011
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