NDC 71819-009 Dermaharmony Bar Peppermint

Salicylic Acid, Sulfur

NDC Product Information

Dermaharmony Bar Peppermint with NDC 71819-009 is a a human over the counter drug product labeled by D3 Development, Inc.. The generic name of Dermaharmony Bar Peppermint is salicylic acid, sulfur. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: D3 Development, Inc.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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 Bar Peppermint 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.

  • SULFUR 5 g/100g
  • SALICYLIC ACID 2 g/100g

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)
  • WATER (UNII: 059QF0KO0R)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • SODIUM ISETHIONATE (UNII: 3R36J71C17)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • COCONUT ACID (UNII: 40U37V505D)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)
  • DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)
  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • OATMEAL (UNII: 8PI54V663Y)
  • SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
  • SUCROSE COCOATE (UNII: 3H18P0UK73)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)

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: 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: 10-26-2020 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.

Dermaharmony Bar Peppermint Product Label Images

Dermaharmony Bar Peppermint 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 04101Made in USA of U.S. and imported ingredientsNDC 71819-009-04

Otc - Active Ingredient

Active ingredientSalicylic Acid 2%Sulfur 5%

Otc - Purpose

PurposeDandruff / sebhorreic dermatitis / psoriasis shampoo

Indications & Usage

Uses​Helps stop the symptoms of dandruff, sebhorreic dermatitis, and psoriasis.

Warnings

WarningsFor external use only

Otc - Ask Doctor

Ask a doctor before use if you have a condition that 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 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

  • DirectionsUse on affected areas in place of your regular shampooFor best results use at least twice a week or as directed by a doctorRub between hands to create a lather, or apply bar directly onto hairMassage into the hair and scalp for 60-90 seconds; then rinse well

Storage And Handling

  • Other informationStore at room temperature

Inactive Ingredient

Inactive ingredientsSodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, peppermint (Mentha Piperita) oil, coco glucoside, water, sodium methyl 2 sulfolaurate & disodium-2-sulfolaurate, cetearyl alcohol & ceteareth-20, tetrasodium glutamate diacetate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, sodium isostearoyl lactylate

Otc - Questions

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

* Please review the disclaimer below.