NDC 59779-355 Eczema Care

Colloidal Oatmeal

NDC Product Code 59779-355

NDC Code: 59779-355

Proprietary Name: Eczema Care 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.


Code Structure
  • 59779 - Cvs Pharmacy
    • 59779-355 - Eczema Care

NDC 59779-355-05

Package Description: 142 mL in 1 TUBE

NDC 59779-355-07

Package Description: 216 mL in 1 TUBE

NDC 59779-355-12

Package Description: 354 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Eczema Care with NDC 59779-355 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Eczema Care is colloidal oatmeal. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Cvs Pharmacy

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Care 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
  • OATMEAL 10 mg/mL
  • 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • OAT (UNII: Z6J799EAJK)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • ISOCETYL ALCOHOL (UNII: 1800H64066)
  • CERAMIDE NP (UNII: 4370DF050B)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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.
  • 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: Cvs Pharmacy
Labeler Code: 59779
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: 12-03-2012 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: 12-31-2019 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 Care Product Label Images

Eczema Care 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 itching and irritation due to eczema.

Warnings

For external use only.

When Using This Product

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

Stop Using This Product And Ask A Doctor If

  • Condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days.

Keep Out Of Reach Of Children.

  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • For mild to moderate eczema only, apply as needed or as directed by a physician.

Other Information

  • Store at room temperature.

Inactive Ingredients

Water (Aqua), Glycerin, Distearyldimonium Chloride, Panthenol, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

* Please review the disclaimer below.

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