anubis barcelona regul oil

Generic: peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract

Labeler: anubis cosmetics sl
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name anubis barcelona regul oil
Generic Name peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract
Labeler anubis cosmetics sl
Dosage Form CONCENTRATE
Routes
TOPICAL
Active Ingredients

alcohol 3.512 mL/10mL, allantoin .025 g/10mL, arctium lappa root .00007 g/10mL, ascorbyl palmitate .0001 g/10mL, butylparaben .0000005 g/10mL, citral .000194 g/10mL, ethylparaben .0000003 g/10mL, farnesol .001 g/10mL, fd&c yellow no. 5 .00002 g/10mL, fragrance 13576 .02 g/10mL, hydroxyethyl cellulose, unspecified .034 g/10mL, isopropyl alcohol .0012 g/10mL, levomenol .009 g/10mL, limonene, (+)- .00419 g/10mL, methylparaben .0100013 g/10mL, niacinamide .0002 g/10mL, panthenol .005 g/10mL, phenoxyethanol .000006 g/10mL, polyoxyl 40 hydrogenated castor oil .04 g/10mL, powdered cellulose .0006 g/10mL, propylene glycol .0138 g/10mL, propylparaben .0000002 g/10mL, riboflavin .000006 g/10mL, tioxolone .02 g/10mL, tocopherol .000002 g/10mL, water 6.2503117 mL/10mL, yeast, unspecified .0345 g/10mL

Manufacturer
ANUBIS COSMETICS SL

Identifiers & Regulatory

Product NDC 83021-624
Product ID 83021-624_0452a0dd-b516-29ea-e063-6294a90aecca
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number M006
Marketing Start 2022-10-21
Marketing End 2027-07-07

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83021624
Hyphenated Format 83021-624

Supplemental Identifiers

UPC
8436019940624
UNII
3K9958V90M 344S277G0Z 597E9BI3Z3 QN83US2B0N 3QPI1U3FV8 T7EU0O9VPP 14255EXE39 EB41QIU6JL I753WB2F1M 5EM498GW35 T4V6TWG28D ND2M416302 24WE03BX2T GFD7C86Q1W A2I8C7HI9T 25X51I8RD4 WV9CM0O67Z HIE492ZZ3T 7YC686GQ8F SMD1X3XO9M 6DC9Q167V3 Z8IX2SC1OH TLM2976OFR S0FAJ1R9CD R0ZB2556P8 059QF0KO0R 3NY3SM6B8U
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name anubis barcelona regul oil (source: ndc)
Generic Name peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract (source: ndc)
Application Number M006 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3.512 mL/10mL
  • .025 g/10mL
  • .00007 g/10mL
  • .0001 g/10mL
  • .0000005 g/10mL
  • .000194 g/10mL
  • .0000003 g/10mL
  • .001 g/10mL
  • .00002 g/10mL
  • .02 g/10mL
  • .034 g/10mL
  • .0012 g/10mL
  • .009 g/10mL
  • .00419 g/10mL
  • .0100013 g/10mL
  • .0002 g/10mL
  • .005 g/10mL
  • .000006 g/10mL
  • .04 g/10mL
  • .0006 g/10mL
  • .0138 g/10mL
  • .0000002 g/10mL
  • .000002 g/10mL
  • 6.2503117 mL/10mL
  • .0345 g/10mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10)
source: ndc

Packages (1)

83021-624-10 10 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10)

Ingredients (27)

alcohol (3.512 mL/10mL) allantoin (.025 g/10mL) arctium lappa root (.00007 g/10mL) ascorbyl palmitate (.0001 g/10mL) butylparaben (.0000005 g/10mL) citral (.000194 g/10mL) ethylparaben (.0000003 g/10mL) farnesol (.001 g/10mL) fd&c yellow no. 5 (.00002 g/10mL) fragrance 13576 (.02 g/10mL) hydroxyethyl cellulose, unspecified (.034 g/10mL) isopropyl alcohol (.0012 g/10mL) levomenol (.009 g/10mL) limonene, (+)- (.00419 g/10mL) methylparaben (.0100013 g/10mL) niacinamide (.0002 g/10mL) panthenol (.005 g/10mL) phenoxyethanol (.000006 g/10mL) polyoxyl 40 hydrogenated castor oil (.04 g/10mL) powdered cellulose (.0006 g/10mL) propylene glycol (.0138 g/10mL) propylparaben (.0000002 g/10mL) riboflavin (.000006 g/10mL) tioxolone (.02 g/10mL) tocopherol (.000002 g/10mL) water (6.2503117 mL/10mL) yeast, unspecified (.0345 g/10mL)

Linked Drug Pages (1)

Anubis Barcelona Regul OIl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0452a0dd-b516-29ea-e063-6294a90aecca", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["8436019940624"], "unii": ["3K9958V90M", "344S277G0Z", "597E9BI3Z3", "QN83US2B0N", "3QPI1U3FV8", "T7EU0O9VPP", "14255EXE39", "EB41QIU6JL", "I753WB2F1M", "5EM498GW35", "T4V6TWG28D", "ND2M416302", "24WE03BX2T", "GFD7C86Q1W", "A2I8C7HI9T", "25X51I8RD4", "WV9CM0O67Z", "HIE492ZZ3T", "7YC686GQ8F", "SMD1X3XO9M", "6DC9Q167V3", "Z8IX2SC1OH", "TLM2976OFR", "S0FAJ1R9CD", "R0ZB2556P8", "059QF0KO0R", "3NY3SM6B8U"], "spl_set_id": ["eb905bd0-c600-b8b2-e053-2995a90ad259"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["ANUBIS COSMETICS SL"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE, WITH APPLICATOR (83021-624-10)", "package_ndc": "83021-624-10", "marketing_end_date": "20270707", "marketing_start_date": "20221021"}], "brand_name": "Anubis Barcelona Regul OIl", "product_id": "83021-624_0452a0dd-b516-29ea-e063-6294a90aecca", "dosage_form": "CONCENTRATE", "pharm_class": ["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]"], "product_ndc": "83021-624", "generic_name": "Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root Extract", "labeler_name": "ANUBIS COSMETICS SL", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anubis Barcelona Regul OIl", "active_ingredients": [{"name": "ALCOHOL", "strength": "3.512 mL/10mL"}, {"name": "ALLANTOIN", "strength": ".025 g/10mL"}, {"name": "ARCTIUM LAPPA ROOT", "strength": ".00007 g/10mL"}, {"name": "ASCORBYL PALMITATE", "strength": ".0001 g/10mL"}, {"name": "BUTYLPARABEN", "strength": ".0000005 g/10mL"}, {"name": "CITRAL", "strength": ".000194 g/10mL"}, {"name": "ETHYLPARABEN", "strength": ".0000003 g/10mL"}, {"name": "FARNESOL", "strength": ".001 g/10mL"}, {"name": "FD&C YELLOW NO. 5", "strength": ".00002 g/10mL"}, {"name": "FRAGRANCE 13576", "strength": ".02 g/10mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "strength": ".034 g/10mL"}, {"name": "ISOPROPYL ALCOHOL", "strength": ".0012 g/10mL"}, {"name": "LEVOMENOL", "strength": ".009 g/10mL"}, {"name": "LIMONENE, (+)-", "strength": ".00419 g/10mL"}, {"name": "METHYLPARABEN", "strength": ".0100013 g/10mL"}, {"name": "NIACINAMIDE", "strength": ".0002 g/10mL"}, {"name": "PANTHENOL", "strength": ".005 g/10mL"}, {"name": "PHENOXYETHANOL", "strength": ".000006 g/10mL"}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "strength": ".04 g/10mL"}, {"name": "POWDERED CELLULOSE", "strength": ".0006 g/10mL"}, {"name": "PROPYLENE GLYCOL", "strength": ".0138 g/10mL"}, {"name": "PROPYLPARABEN", "strength": ".0000002 g/10mL"}, {"name": "RIBOFLAVIN", "strength": ".000006 g/10mL"}, {"name": "TIOXOLONE", "strength": ".02 g/10mL"}, {"name": "TOCOPHEROL", "strength": ".000002 g/10mL"}, {"name": "WATER", "strength": "6.2503117 mL/10mL"}, {"name": "YEAST, UNSPECIFIED", "strength": ".0345 g/10mL"}], "application_number": "M006", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_end_date": "20270707", "marketing_start_date": "20221021"}