NDC 73113-010 Pedatosol


NDC Product Code 73113-010

NDC Product Information

Pedatosol with NDC 73113-010 is a a human over the counter drug product labeled by Mh Global Co., Ltd.. The generic name of Pedatosol is oatmeal. The product's dosage form is solution and is administered via topical form.

Labeler Name: Mh Global Co., Ltd.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Pedatosol 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.

  • OATMEAL 2.99 g/70mL

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)

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: Mh Global Co., Ltd.
Labeler Code: 73113
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-01-2019 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.

Pedatosol Product Label Images

Pedatosol 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

Active ingredients: Colloidal Oatmeals 4.28 %

Inactive Ingredient

Inactive ingredients:Lactobacillus Ferment Extract, Water, Cocos Nucifera (Coconut) Oil, 1,2-Hexanediol, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Beta-Glucan, Citrus Grandis (Grapefruit) Seed Extract


Purpose: Skin Protectant


Warnings:For external use only. When Using this • Do not get into eyes. - In case of the following symptoms, you should cease usage; if the symptoms get worse due to the continued use, visit the professionals for consulting- In case of any abnormal symptoms or side effects such as red spots, swelling or itching by direct sunlight, visit a specialist for consulting when using or after usage. Do not use on wounded sites, from external natures. Keep out of reach of children. Store at room temperature.

Keep Out Of Reach Of Children



Uses:Helps Skin Moisturization and Reproduction of the Childs with Pediatric dermatitis, including atopic dermatitis.


Directions:To expect outstanding improvements, please consistently apply the sufficient amount of the solution for two-three times per day at least. That does not mean that you mustn’t use it more than the above dates and procedures.

* Please review the disclaimer below.