H Plus Holdings Nourishing
Salicylic Acid
Prime Enterprises
Human Otc Drug
NDC 58443-0249H Plus Holdings Nourishing also known as Salicylic Acid is a human otc drug labeled by 'Prime Enterprises'. National Drug Code (NDC) number for H Plus Holdings Nourishing is 58443-0249. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in H Plus Holdings Nourishing drug includes Salicylic Acid - 17.575 mg/mL . The currest status of H Plus Holdings Nourishing drug is Active.
Drug Information:
| Drug NDC: | 58443-0249 |
| 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: | H Plus Holdings Nourishing |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | H Plus Holdings |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Nourishing |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Prime Enterprises |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| 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 - 17.575 mg/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: | 13 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Prime Enterprises
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0860006790127
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 58443-0249-4 | 237 mL in 1 TUBE (58443-0249-4) | 13 Jun, 2019 | 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 anti-dandruff
Product Elements:
H plus holdings nourishing salicylic acid dicetyldimonium chloride isomalt alcohol behentrimonium chloride stearyl alcohol oat phymatolithon calcareum isopropyl alcohol .alpha.-tocopherol acetate dimethicone benzyl alcohol isopropyl palmitate menthol water butylene glycol lecithin, soybean poloxamer 407 willow bark pseudopterogorgia elisabethae ethylhexylglycerin glycereth-26 glycerin rhododendron ferrugineum leaf 4-terpineol, (+/-)- allantoin methylpropanediol phenoxyethanol sodium hydroxide guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) medium-chain triglycerides salicylic acid salicylic acid dipropylene glycol laminaria digitata cetyl alcohol distearyldimonium chloride
Indications and Usage:
Uses helps prevent reoccurance of flaking and itching associated with dandruff.
Warnings:
Warnings for external use only.
When Using:
Avoid contact wih the eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Directions gently massage into scalp and work through hair to the ends. leave on 30 seconds for normal hair and 2-3 minutes for damaged and/or processed hair. rinse with warm water, dry and style as usual. for best results use at least twice a week or as directed by a doctor. store at room temperature.
Package Label Principal Display Panel:
H plus 1.85% salicylic acid anti-dandruff conditioner 8 fl. oz. principle display label