NDC 69366-503 Honest Eczema Balm

Colloidal Oatmeal

NDC Product Code 69366-503

NDC Code: 69366-503

Proprietary Name: Honest Eczema Balm 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: Colloidal 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

  • 69366 - The Honest Company, Inc.
    • 69366-503 - Honest Eczema Balm

NDC 69366-503-20

Package Description: 1 JAR in 1 CARTON > 85 g in 1 JAR

NDC Product Information

Honest Eczema Balm with NDC 69366-503 is a a human over the counter drug product labeled by The Honest Company, Inc.. The generic name of Honest Eczema Balm is colloidal oatmeal. The product's dosage form is ointment and is administered via topical form.

Labeler Name: The Honest Company, Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Honest Eczema Balm 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 1 g/100g

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)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • APPLE (UNII: B423VGH5S9)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SQUALANE (UNII: GW89575KF9)
  • ALLANTOIN (UNII: 344S277G0Z)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: The Honest Company, Inc.
Labeler Code: 69366
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: 07-01-2019 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.

Honest Eczema Balm 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%

Purpose

Skin protectant

Uses:

  • Temporarily protects and helps relieve minor skin irritation due to: •eczema •rashes

Warnings:

For external use only.

When Using This Product

  • •do not get into eyes.

Stop Use And Ask A Doctor If

  • •condition worsens •symptoms last more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Apply as needed. Safe to use every day on baby's sensitive skin.

Other Information:

  • •Store at room temperature.

Inactive Ingredients:

Water (Aqua), Carthamus Tinctorius (Safflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Coco-Caprylate/Caprate, Disteardimonium Hectorite, Propanediol, Bambusa Arundinacea Stem Extract, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-3 Diisostearate, Magnesium Sulfate, Polyglyceryl-6 Polyricinoleate, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Pyrus Malus (Apple) Fruit Extract, Isosorbide Disunflowerseedate, Aloe Barbadensis Leaf Juice, Alpha-Glucan Oligosaccharide, Glycerin, Squalane, Allantoin, Tocopherol, 1,2-Hexanediol, Caprylhydroxamic Acid, Trisodium Ethylenediamine Disuccinate, Potassium Sorbate, Sodium Benzoate

* Please review the disclaimer below.

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