Denorex Extra Strength
Salicylic Acid
Neoteric Cosmetics, Inc.
Human Otc Drug
NDC 62673-058Denorex Extra Strength also known as Salicylic Acid is a human otc drug labeled by 'Neoteric Cosmetics, Inc.'. National Drug Code (NDC) number for Denorex Extra Strength is 62673-058. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Denorex Extra Strength drug includes Salicylic Acid - .03 g/mL . The currest status of Denorex Extra Strength drug is Active.
Drug Information:
| Drug NDC: | 62673-058 |
| 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: | Denorex Extra Strength |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Neoteric Cosmetics, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Shampoo |
| 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 - .03 g/mL
|
| 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: | 01 Nov, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jun, 2026 |
| 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: | Neoteric Cosmetics, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 205023
1303358
|
| 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
|
| 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 |
|---|
| 62673-058-10 | 296 mL in 1 BOTTLE (62673-058-10) | 13 Dec, 2017 | 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 controls the symptoms of dandruff, seborrheic dermatitis and psoriasis
Product Elements:
Denorex extra strength salicylic acid water sodium c14-16 olefin sulfonate propylene glycol glycol distearate menthol cocamidopropyl betaine panthenol .alpha.-tocopherol acetate sodium citrate fd&c yellow no. 6 d&c yellow no. 10 d&c red no. 33 fd&c blue no. 1 salicylic acid salicylic acid
Indications and Usage:
Uses reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis
Warnings:
Warnings for external use only. ask a doctor before use if you have a condition that covers a large area of the body. when using this product avoid contact with the eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with the eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Directions shake well apply to wet hair gently massage into hair and scalp to work up a lather rinse thoroughly and repeat for best results, use at least twice weekly or as directed by a doctor
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
Principal display panel extra strength denorex 3 % salicylic acid dandruff control shampoo + conditioner 10 fl oz (296 ml) den0059.jpg extra strength denorex 3 % salicylic acid dandruff control shampoo + conditioner 10 fl oz (296 ml)