Metaderm Scalp And Body
NDC 58133-380

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58133-380?
  4. Metaderm Scalp And Body Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Metaderm Scalp And Body is a UNAPPROVED HOMEOPATHIC-approved product labeled by Cosmetic Specialty Labs, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 58133-380 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58133-380
Proprietary Name:
Metaderm Scalp And Body
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Cosmetic Specialty Labs, Inc.
Labeler Code:
58133
Product Label ID:
738ffed7-bec5-2861-e053-2991aa0a6d93
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
08-15-2018
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 58133-380?

The NDC code 58133-380 is assigned by the FDA to the product Metaderm Scalp And Body. This pharmaceutical product is labeled by Cosmetic Specialty Labs, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 58133-380-04, 58133-380-32. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Apply liberally at least twice daily, maximal results observed in 12 weeks. If using topical steroids, Metaderm can be added. If stopping steroids, sudden withdrawal can result in flare, taper as necessary.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
  • MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (Active Moiety)
  • SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)
  • SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (Active Moiety)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (Active Moiety)
  • BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3)
  • BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (Active Moiety)
  • CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K)
  • CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K) (Active Moiety)
  • RHUS SPP. WHOLE (UNII: 3U7FG9T9MW)
  • RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (Active Moiety)
  • PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9)
  • PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9) (Active Moiety)
  • AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)
  • AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".