58133-390 NDC - METADERM ECZEMA BODY AND SCALP AND BABY BODY AND SCALP (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, BERBERIS VULGARIS, CONIUM MACULATUM, MATRICARIA CHAMOMILLA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS)

Drug Information

Product NDC: 58133-390

Proprietary Name: Metaderm Eczema Body and Scalp and Baby Body and Scalp

Non Proprietary Name: Achillea millefolium, Aesculus hippocastanum, Berberis vulgaris, Conium maculatum, Matricaria chamomilla, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis

Active Ingredient(s):
  • 4 [hp_M]/mL ACHILLEA MILLEFOLIUM;
  • 4 [hp_M]/mL AESCULUS HIPPOCASTANUM SEED OIL;
  • 9 [hp_M]/mL BERBERIS VULGARIS FRUIT;
  • 21 [hp_M]/mL CONIUM MACULATUM FRUIT;
  • 5 [hp_M]/mL MATRICARIA CHAMOMILLA FLOWERING TOP OIL;
  • 110 [hp_M]/mL PHYTOLACCA OCTANDRA LEAF;
  • 13 [hp_M]/mL RHUS SPP. WHOLE;
  • 8 [hp_M]/mL SANGUINARIA CANADENSIS ROOT


Administration Route(s): TOPICAL

Dosage Form(s): SPRAY

Labeler Information

Labeler Name: Cosmetic Specialty Labs, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/15/2018

Package Information

No. Package Code Package Description Billing Unit
158133-390-04118 mL in 1 BOTTLE, SPRAY (58133-390-04)
258133-390-32950 mL in 1 BOTTLE (58133-390-32)
358133-390-33950 mL in 1 BOTTLE (58133-390-33)
458133-390-40118 mL in 1 BOTTLE, SPRAY (58133-390-40)

NDC Record

Field Name Field Value Definition
PRODUCT NDC58133-390The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEMetaderm Eczema Body and Scalp and Baby Body and ScalpThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAchillea millefolium, Aesculus hippocastanum, Berberis vulgaris, Conium maculatum, Matricaria chamomilla, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensisThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/15/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMECosmetic Specialty Labs, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACHILLEA MILLEFOLIUM; AESCULUS HIPPOCASTANUM SEED OIL; BERBERIS VULGARIS FRUIT; CONIUM MACULATUM FRUIT; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; PHYTOLACCA OCTANDRA LEAF; RHUS SPP. WHOLE; SANGUINARIA CANADENSIS ROOTAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH4; 4; 9; 21; 5; 110; 13; 8 
ACTIVE INGRED UNIT[hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL 

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This page was last updated on: 2/1/2023