NDC 80331-177 Not Pot Oat Puff Cbd Eczema

Oatmeal

NDC Product Code 80331-177

NDC 80331-177-00

Package Description: 88 mL in 1 TUBE

NDC Product Information

Not Pot Oat Puff Cbd Eczema with NDC 80331-177 is a a human over the counter drug product labeled by Blemish Inc.. The generic name of Not Pot Oat Puff Cbd Eczema is oatmeal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Blemish Inc.

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.

Not Pot Oat Puff Cbd Eczema 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 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)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CUCUMBER SEED (UNII: BT3S9L53JK)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • SUNFLOWER SEED (UNII: R9N3379M4Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 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.
  • 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: Blemish Inc.
Labeler Code: 80331
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: 10-01-2020 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: 12-31-2021 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.

Not Pot Oat Puff Cbd Eczema Product Label Images

Not Pot Oat Puff Cbd Eczema 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 Ingredients

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Indications

  • Temporarily protects and helps relieve minor skin irritation and itching due to: rasheseczemapoison ivy, oak, or sumacinsect bites.

Warnings

For external use only.

When Using This Product

  • Avoid contact with eyesTo avoid slipping, use mat in tub or showerIn some skin conditions, soaking too long may over dry If symptoms persist for more than seven days, discontinue use and consult physician

Keep Out Of Reach Of Children.

If swallowed, consult physician

If Pregnant Or Breastfeeding,

  • Contact physician prior to use.

Directions

  • Apply as needed.

Additional Information

Protect the product in this container from excessive heat and direct sun.

Other Ingredients

A-Bisabalol, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Hemp) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Cocos Nucifera (Coconut) Oil, Emulsifying Wax NF, Ethyl Vanillin, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Xanthan Gum.

* Please review the disclaimer below.