H Plus Holdings Nourishing
Hydrocortisone Acetate
Prime Enterprises, Inc.
Human Otc Drug
NDC 58443-0411H Plus Holdings Nourishing also known as Hydrocortisone Acetate is a human otc drug labeled by 'Prime Enterprises, Inc.'. National Drug Code (NDC) number for H Plus Holdings Nourishing is 58443-0411. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in H Plus Holdings Nourishing drug includes Hydrocortisone - 10.2 mg/mL . The currest status of H Plus Holdings Nourishing drug is Active.
Drug Information:
| Drug NDC: | 58443-0411 |
| 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: | Hydrocortisone Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Prime Enterprises, 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: | HYDROCORTISONE - 10.2 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 NOT 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: | 12 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | part348 |
| 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, Inc.
|
| 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: | 0860006790103
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175576
N0000175450
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WI4X0X7BPJ
|
| 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. |
| Pharmacologic Class MOA: | Corticosteroid Hormone Receptor Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Corticosteroid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58443-0411-4 | 237 mL in 1 BOTTLE (58443-0411-4) | 12 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 antipuritic (anti-itch)
Product Elements:
H plus holdings nourishing hydrocortisone acetate hydrocortisone hydrocortisone benzyl alcohol citric acid monohydrate isopropyl palmitate menthol water butylene glycol cocamidopropyl betaine decyl glucoside lecithin, soybean poloxamer 407 willow bark pseudopterogorgia elisabethae sodium lauroamphoacetate butylated hydroxytoluene 4-terpineol, (+/-)- allantoin rhododendron ferrugineum leaf methylpropanediol sodium lauroyl methyl isethionate phenoxyethanol salicylic acid sodium cocoyl isethionate sodium methyl cocoyl taurate lactic acid sodium hydroxide isomalt ethylhexylglycerin glycereth-26 glycerin glycol stearate guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) edetate disodium anhydrous medium-chain triglycerides white pearl
Indications and Usage:
Uses for the temporary relief of itching associated with minor skin irritations and rashes.
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 apply a quarter-sized amount to the top of the head and another quarter-sized amount to the sides of wet hair and scalp. add additional water and cleanser for increased lather. massage lather into scalp and rinse thoroughly with warm water. use daily or minimum of 3 times per week. children under 2 years of age: do not use, consult a doctor. store at room temperature.
Package Label Principal Display Panel:
Hair sanity anti-itch shampoo step 1 principle display label