NDC 71070-968 Balshi Md Calming Hemp Seed For Eczema Relief

Oatmeal

NDC Product Code 71070-968

NDC Code: 71070-968

Proprietary Name: Balshi Md Calming Hemp Seed For Eczema Relief 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: Oatmeal 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.

NDC Code Structure

  • 71070 - Balshi Md Dermaceuticals
    • 71070-968 - Balshi Md Calming Hemp Seed For Eczema Relief

NDC 71070-968-03

Package Description: 100 mL in 1 BOTTLE, PUMP

NDC Product Information

Balshi Md Calming Hemp Seed For Eczema Relief with NDC 71070-968 is a a human over the counter drug product labeled by Balshi Md Dermaceuticals. The generic name of Balshi Md Calming Hemp Seed For Eczema Relief is oatmeal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Balshi Md Dermaceuticals

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 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.

Balshi Md Calming Hemp Seed For Eczema Relief 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 10 mg/mL

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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • CHAMOMILE (UNII: FGL3685T2X)
  • EMU OIL (UNII: 344821WD61)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LICORICE (UNII: 61ZBX54883)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • MENTHOL (UNII: L7T10EIP3A)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Balshi Md Dermaceuticals
Labeler Code: 71070
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: 08-01-2019 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.

Balshi Md Calming Hemp Seed For Eczema Relief Product Label Images

Balshi Md Calming Hemp Seed For Eczema Relief 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:

Colloidal Oatmeal 1.00%

Purpose

Skin Protectant

Indications:

Temporarily protects and helps relieve minor skin irritation and ditching to due to Eczema or rashes.

Warnings:

For external use only. Avoid contact with eyes.If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

If swallowed, consult physician.

Directions:

Adults and children two-years of age or older: Apply as needed. Children under two-years of age: consult a physician.

Additional Information:

For use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Other Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, a-Bisabalol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Menthol, Phenoxyethanol, Potassium Sorbate, Xanthan Gum.

* Please review the disclaimer below.

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