NDC 73672-983 Eczema Relief Cream

Colloidal Oatmeal 1%

NDC Product Code 73672-983

NDC 73672-983-50

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Eczema Relief Cream with NDC 73672-983 is a a human over the counter drug product labeled by Metacan Inc Ste. The generic name of Eczema Relief Cream is colloidal oatmeal 1%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Metacan Inc Ste

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.

Eczema Relief Cream 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.

  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • JOJOBA OIL (UNII: 724GKU717M)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • HEMP (UNII: TD1MUT01Q7)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BLACK PEPPER OIL (UNII: U17J84S19Z)
  • CLOVE OIL (UNII: 578389D6D0)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • ALOE (UNII: V5VD430YW9)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALLANTOIN (UNII: 344S277G0Z)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • MYELOPEROXIDASE (UNII: JQZ6YM58U5)
  • GLUCOSE OXIDASE (UNII: 0T8392U5N1)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)

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: Metacan Inc Ste
Labeler Code: 73672
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: 02-10-2020 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.

Eczema Relief Cream 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

Colloidal Oatmeal 1%...Skin Protectant

Uses

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

Warnings

For external use only

Otc - When Using

  • When using this productdo not get into eyes

Otc - Stop Use

  • Stop use and ask doctor ifcondition worsenssymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

Other Information

  • Store in a cool dry place away from light

Inactive Ingredients

Water (aqua), coco-caprylate, organic shea (butyrospermum parkii) butter, organic jojoba (simmondsia chinensis) seed oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, sorbitan olivate, organic aloe (aloe barbadensis) leaf juice, cetearyl glucoside, ethylhexylglycerin, glucose,allantoin, xanthan gum, linalool, limonene, lactoperoxidase, glucose oxidase, organic lavender (lavandula angustifolia) oil, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic geranium (pelargonium graveolens) flower oi

* Please review the disclaimer below.