NDC 73503-004 Psodex Eczema Therapy Moisturizing

Oatmeal, Mineral

NDC Product Code 73503-004

NDC 73503-004-01

Package Description: 1 BOTTLE in 1 BOX > 100 mL in 1 BOTTLE

NDC Product Information

Psodex Eczema Therapy Moisturizing with NDC 73503-004 is a a human over the counter drug product labeled by Psodex Usa Inc.. The generic name of Psodex Eczema Therapy Moisturizing is oatmeal, mineral. The product's dosage form is cream and is administered via topical form.

Labeler Name: Psodex Usa 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.

Psodex Eczema Therapy Moisturizing 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 .06 mg/mL
  • MINERAL OIL 300 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)
  • BORAGE SEED OIL (UNII: F8XAG1755S)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • TURMERIC (UNII: 856YO1Z64F)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NIACIN (UNII: 2679MF687A)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

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: Psodex Usa Inc.
Labeler Code: 73503
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: 03-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Psodex Eczema Therapy Moisturizing Product Label Images

Psodex Eczema Therapy Moisturizing 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: 0,006%Mineral Oil: 30%

Purpose

Skin protectant cream

Use

  • Temporarily protects and helps to relieve minor skin irritation and itching due to:EczemaRashes

Warnings

For external use only

When Using This Product

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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 right away.

Directions

Apply as needed

Other Information

Store at controlled room temperature 15°-30°C  (59°-86°F)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, Borage Seed Oil, Caprylyl Glycol, Centella Asiatica Whole Extract, Cetearyl Alcohol, Cetearyl Olivate, Colloidal Oatmeal, Curcuma Longa Extract, D -Camphor Natural, D-Panthenol, Distilled Water, Ethylhexylglycerin, Fumaria Officinalis Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropyl Myristate, Liquid Paraffin, Mentha Piperita Leaf Extract, Petroleum Jelly (Vasaline), Sorbitan Olivate, Stearic Acid, Tea Tree Leaf Oil, Vegetable Glycerin, Vitamin B3, Vitamin E

* Please review the disclaimer below.