Psoriaflora
Mahonia Aquifolium Root Bark
Schwabe North America, Inc
Human Otc Drug
NDC 53499-1990Psoriaflora also known as Mahonia Aquifolium Root Bark is a human otc drug labeled by 'Schwabe North America, Inc'. National Drug Code (NDC) number for Psoriaflora is 53499-1990. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Psoriaflora drug includes Mahonia Aquifolium Root Bark - 2 [hp_X]/28g . The currest status of Psoriaflora drug is Active.
Drug Information:
| Drug NDC: | 53499-1990 |
| 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: | Psoriaflora |
| 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: | Mahonia Aquifolium Root Bark |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Schwabe North America, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | MAHONIA AQUIFOLIUM ROOT BARK - 2 [hp_X]/28g
|
| 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: | UNAPPROVED HOMEOPATHIC |
| 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 Jan, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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. |
| 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: | Schwabe North America, 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. |
| UNII: | VZJ9F3C3SB
|
| 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 |
|---|
| 53499-1990-4 | 1 TUBE in 1 CARTON (53499-1990-4) / 28 g in 1 TUBE | 01 Jan, 2006 | 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 temporarily relieves the dryness, itching, flaking, rash, redness and skin irritation associated with psoriasis.
Product Elements:
Psoriaflora mahonia aquifolium root bark mahonia aquifolium root bark mahonia aquifolium root bark benzyl alcohol cetyl alcohol alcohol glycol stearate isopropyl myristate mineral oil potassium hydroxide water stearyl heptanoate
Indications and Usage:
Indications & usage temporarily relieves the dryness, itching, flaking, rash, redness and skin irritation associated with psoriasis.
Warnings:
Warnings for external use only. avoid contact with eyes or broken skin.
Do Not Use:
Warnings for external use only. avoid contact with eyes or broken skin.
Dosage and Administration:
Dosage & administration directions : adults and children 2 years of age and older: apply to affected area up to 4 times daily. rub in gently. children under 2 years of age: consult a physician. patch test recommended on sensitive skin.
Stop Use:
Stop use stop use and ask a doctor if increased skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days. these could be signs of a serious condition.
Overdosage:
Overdosage if swallowed, seek medical help or contact a poison control center immediately.
Package Label Principal Display Panel:
Lbn21850990.a02 z psoriaflora cream 1 oz.jpg