NDC 71819-002 Dermaharmony Seborrheic Dermatitis

Pyrithione Zinc

NDC Product Code 71819-002

NDC Code: 71819-002

Proprietary Name: Dermaharmony Seborrheic Dermatitis 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: Pyrithione Zinc 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.

NDC Code Structure

  • 71819 - D3 Development, Inc.
    • 71819-002 - Dermaharmony Seborrheic Dermatitis

NDC 71819-002-03

Package Description: 89 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dermaharmony Seborrheic Dermatitis with NDC 71819-002 is a a human over the counter drug product labeled by D3 Development, Inc.. The generic name of Dermaharmony Seborrheic Dermatitis is pyrithione zinc. The product's dosage form is cream and is administered via topical form.

Labeler Name: D3 Development, 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.

Dermaharmony Seborrheic Dermatitis 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.

  • PYRITHIONE ZINC .25 g/100mL

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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%) (UNII: 6OX6A5C7B6)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • WATER (UNII: 059QF0KO0R)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)

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: D3 Development, Inc.
Labeler Code: 71819
FDA Application Number: part358H 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: 07-26-2019 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: 12-31-2020 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.

Dermaharmony Seborrheic Dermatitis Product Label Images

Dermaharmony Seborrheic Dermatitis 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

Other

Drug Facts

Distributed by:D3 Development, Inc.Portland, ME 04101

Otc - Active Ingredient

Active ingredientPyrithione zinc 0.25%

Otc - Purpose

PurposeSeborrheic dermatitis cream

Indications & Usage

  • UsesRelieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitisHelps eliminate recurrence of seborrheic dermatitis

Warnings

WarningsFor external use only

Otc - Ask Doctor

Ask a doctor before use if condition covers a large area of the body.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.

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

DirectionsApply to affected area one to four times daily

Storage And Handling

  • Other informationStore at 59° to 77°F (15° to 25°C)Lot number and expiration date can be found on lid.

Inactive Ingredient

Inactive ingredientsWater, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose

Otc - Questions

Questions?1-800-827-3730www.dermaharmony.com

* Please review the disclaimer below.

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