83021-624 NDC - ANUBIS BARCELONA REGUL OIL (PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT)

Drug Information

Product NDC: 83021-624

Proprietary Name: Anubis Barcelona Regul OIl

Non Proprietary Name: Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root Extract

Active Ingredient(s):
  • 3.512 mL/10mL ALCOHOL;
  • .025 g/10mL ALLANTOIN;
  • .00007 g/10mL ARCTIUM LAPPA ROOT;
  • .0001 g/10mL ASCORBYL PALMITATE;
  • .0000005 g/10mL BUTYLPARABEN;
  • .000194 g/10mL CITRAL;
  • .0000003 g/10mL ETHYLPARABEN;
  • .001 g/10mL FARNESOL;
  • .00002 g/10mL FD&C YELLOW NO. 5;
  • .02 g/10mL FRAGRANCE 13576;
  • .034 g/10mL HYDROXYETHYL CELLULOSE, UNSPECIFIED;
  • .0012 g/10mL ISOPROPYL ALCOHOL;
  • .009 g/10mL LEVOMENOL;
  • .00419 g/10mL LIMONENE, (+)-;
  • .0100013 g/10mL METHYLPARABEN;
  • .0002 g/10mL NIACINAMIDE;
  • .005 g/10mL PANTHENOL;
  • .000006 g/10mL PHENOXYETHANOL;
  • .04 g/10mL POLYOXYL 40 HYDROGENATED CASTOR OIL;
  • .0006 g/10mL POWDERED CELLULOSE;
  • .0138 g/10mL PROPYLENE GLYCOL;
  • .0000002 g/10mL PROPYLPARABEN;
  • .000006 g/10mL RIBOFLAVIN;
  • .02 g/10mL TIOXOLONE;
  • .000002 g/10mL TOCOPHEROL;
  • 6.2503117 mL/10mL WATER;
  • .0345 g/10mL YEAST, UNSPECIFIED


Administration Route(s): TOPICAL

Dosage Form(s): CONCENTRATE

Pharmacy Class(es):
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Fungal Proteins [CS];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Increased Histamine Release [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Non-Standardized Fungal Allergenic Extract [EPC];
  • Standardized Chemical Allergen [EPC];
  • Standardized Chemical Allergen [EPC];
  • Standardized Chemical Allergen [EPC];
  • Standardized Chemical Allergen [EPC]

Labeler Information

Labeler Name: ANUBIS COSMETICS SL
Product Type: HUMAN OTC DRUG
FDA Application Number: M006
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:10/21/2022

Package Information

No. Package Code Package Description Billing Unit
183021-624-1010 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83021-624The 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 NAMEAnubis Barcelona Regul OIlThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPeg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root ExtractThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECONCENTRATEThe 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 DATE10/21/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERM006This 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.
LABELER NAMEANUBIS COSMETICS SLName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALCOHOL; ALLANTOIN; ARCTIUM LAPPA ROOT; ASCORBYL PALMITATE; BUTYLPARABEN; CITRAL; ETHYLPARABEN; FARNESOL; FD&C YELLOW NO. 5; FRAGRANCE 13576; HYDROXYETHYL CELLULOSE, UNSPECIFIED; ISOPROPYL ALCOHOL; LEVOMENOL; LIMONENE, (+)-; METHYLPARABEN; NIACINAMIDE; PANTHENOL; PHENOXYETHANOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; POWDERED CELLULOSE; PROPYLENE GLYCOL; PROPYLPARABEN; RIBOFLAVIN; TIOXOLONE; TOCOPHEROL; WATER; YEAST, UNSPECIFIEDAn 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 STRENGTH3.512; .025; .00007; .0001; .0000005; .000194; .0000003; .001; .00002; .02; .034; .0012; .009; .00419; .0100013; .0002; .005; .000006; .04; .0006; .0138; .0000002; .000006; .02; .000002; 6.2503117; .0345 
ACTIVE INGRED UNITmL/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; g/10mL; mL/10mL; g/10mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC] 

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