Dermaharmony Sulfur And Salicylic Acid
Salicylic Acid, Sulfur
D3 Development, Inc.
Human Otc Drug
NDC 71819-006Dermaharmony Sulfur And Salicylic Acid also known as Salicylic Acid, Sulfur is a human otc drug labeled by 'D3 Development, Inc.'. National Drug Code (NDC) number for Dermaharmony Sulfur And Salicylic Acid is 71819-006. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Dermaharmony Sulfur And Salicylic Acid drug includes Salicylic Acid - 2 g/100mL Sulfur - 5 g/100mL . The currest status of Dermaharmony Sulfur And Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 71819-006 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dermaharmony Sulfur And Salicylic Acid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Salicylic Acid, Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | D3 Development, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SALICYLIC ACID - 2 g/100mL
SULFUR - 5 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 27 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| 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. |
| Application Number: | part358H |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | D3 Development, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2286294
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | O414PZ4LPZ
70FD1KFU70
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 71819-006-04 | 118 mL in 1 BOTTLE, PLASTIC (71819-006-04) | 27 Mar, 2020 | N/A | No |
| 71819-006-10 | 296 mL in 1 BOTTLE, PLASTIC (71819-006-10) | 27 Mar, 2020 | N/A | No |
| 71819-006-12 | 355 mL in 1 BOTTLE, PLASTIC (71819-006-12) | 27 Mar, 2020 | N/A | No |
| 71819-006-64 | 1893 mL in 1 BOTTLE, PLASTIC (71819-006-64) | 27 Mar, 2020 | N/A | No |
| 71819-006-99 | 3785 mL in 1 BOTTLE, PLASTIC (71819-006-99) | 27 Mar, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose dandruff / sebhorreic dermatitis / psoriasis soap
Product Elements:
Dermaharmony sulfur and salicylic acid salicylic acid, sulfur acrylic acid carbomer homopolymer type a (allyl pentaerythritol crosslinked) carbomer homopolymer type c (allyl pentaerythritol crosslinked) sulfur sulfur pumice water potassium cocoate glycerin salicylic acid salicylic acid potassium olivate potassium oleate citric acid monohydrate
Indications and Usage:
Uses âhelps prevent and control recurrence of itching, flaking and irritation associated with dandruff, sebhorreic dermatitis, and psoriasis
Warnings:
Warnings for external use only.
When Using:
When using this product, avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Directions use on affected areas in place of your regular soap or shampoo. for best results use at least twice a week or as directed by a doctor. work up a lather using warm water and massage into affected areas. rinse.
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Package Label Principal Display Panel:
Dermaharmony sulfur & salicylic acid soap for dandruff, sebhorreic dermatitis & psoriasis medicated natural castile soap 4 fl oz (118 ml) sulf - sa liq soap 71819-006
Further Questions:
Questions? 1-800-827-3730 www.dermaharmony.com