NDC 54973-4103 Hylands Naturals Eczema
Colloidal Oatmeal Lotion Topical

Product Information

What is NDC 54973-4103?

The NDC code 54973-4103 is assigned by the FDA to the product Hylands Naturals Eczema which is a human over the counter drug product labeled by Hylands. The generic name of Hylands Naturals Eczema is colloidal oatmeal. The product's dosage form is lotion and is administered via topical form. The product is distributed in a single package with assigned NDC code 54973-4103-1 142 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code54973-4103
Proprietary Name 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.		Hylands Naturals Eczema
Non-Proprietary Name 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.		Colloidal Oatmeal
Product Type 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.		Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.		Hylands
Labeler Code54973
FDA Application Number 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.		part347
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		12-05-2022
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Hylands Naturals Eczema?


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC Code 54973-4103-1

Package Description: 142 g in 1 TUBE

Product Details

What are Hylands Naturals Eczema Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Hylands Naturals Eczema Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Hylands Naturals Eczema Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Hylands Naturals Eczema Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts


Otc - Active Ingredient



Active ingredients
Colloidal Oatmeal 1%


Otc - Purpose



Purpose
Skin protectant


Indications & Usage



Uses
Temporarily protects and helps relieve minor skin irritation and itching due to: ■ eczema  ■ rashes


Warnings



Warnings
For external use only. When using this product do not get into eyes
Stop use and ask doctor if ■ condition worsens, ■ symptoms last
for more than 7 days or clear up and occur again within a few days.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center right away.


Dosage & Administration



Directions  ■ Apply as needed.


Inactive Ingredient



Inactive ingredients  Water,Glycerin, Dicaprylyl
Carbonate,Glyceryl Stearate Citrate, Cetearyl Olivate, Sorbitan

Olivate, Lauryl Laurate, Benzyl Alcohol, Dehydroacetic Acid, Shea

Butter, Cocoa Seed Butter, Linseed Seed Oil, Oat, Xanthan Gum,

Organic Sunflower Seed Oil, Organic Lavender Flower Extract,

Organic Calendula Officianalis Flower Extract, Organic Aloe Leaf

Juice, Hydrolized Quinoa, Panthenol, Citric Acid.


Otc - Questions



Questions? www.hylands.com
or [email protected]


Package Labeling



Hylands

NATURALS

• baby •

ECZEMA
LOTION

DERMATOLOGIST TESTED

NET WT. 5 OZ. (142 g)

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Manufactured for: Hyland’s, Inc., PO Box 61067, Los Angeles, CA 90061
www.hylands.com | REV001

res


* Please review the disclaimer below.