Anubis Barcelona Regul Oil is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Anubis Cosmetics Sl. The primary component is Alcohol; Arctium Lappa Root; C13-14 Isoparaffin; Cetearyl Ethylhexanoate; Cetostearyl Alcohol; Ethylhexylglycerin; Fd&c Yellow No. 5; Fragrance 13576; Glycerin; Glyceryl Stearate Se; Hops; Imidurea; Laureth-7; Limonene, (+)-; Methylchloroisothiazolinone; Methylisothiazolinone; Methylparaben; Mineral Oil; Niacinamide; Panthenol; Peg/ppg-20/6 Dimethicone; Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate); Phenoxyethanol; Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide); Propylene Glycol; Propylparaben; Riboflavin; Tioxolone; Triisopropanolamine; Water; Yeast, Unspecified.
| Product ID | 83021-300_eb7c418b-8bef-26a3-e053-2a95a90a4e96 |
| NDC | 83021-300 |
| Product Type | Human Otc Drug |
| Proprietary Name | Anubis Barcelona Regul Oil |
| Generic Name | Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2022-10-20 |
| Marketing Category | OTC MONOGRAPH FINAL / |
| Application Number | M006 |
| Labeler Name | ANUBIS COSMETICS SL |
| Substance Name | ALCOHOL; ARCTIUM LAPPA ROOT; C13-14 ISOPARAFFIN; CETEARYL ETHYLHEXANOATE; CETOSTEARYL ALCOHOL; ETHYLHEXYLGLYCERIN; FD&C YELLOW NO. 5; FRAGRANCE 13576; GLYCERIN; GLYCERYL STEARATE SE; HOPS; IMIDUREA; LAURETH-7; LIMONENE, (+)-; METHYLCHLOROISOTHIAZOLINONE; METHYLISOTHIAZOLINONE; METHYLPARABEN; MINERAL OIL; NIACINAMIDE; PANTHENOL; PEG/PPG-20/6 DIMETHICONE; PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE); PHENOXYETHANOL; POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE); PROPYLENE GLYCOL; PROPYLPARABEN; RIBOFLAVIN; TIOXOLONE; TRIISOPROPANOLAMINE; WATER; YEAST, UNSPECIFIED |
| Active Ingredient Strength | 0 mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; mL/200mL; g/200mL |
| Pharm Classes | Allergens [CS], Allergens [CS], 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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-10-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 83021-300 | Anubis Barcelona Regul Oil | Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (Hops) Cone Extract |
| 83021-624 | Anubis Barcelona Regul OIl | Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Arctium Majus Root Extract |
| 83021-740 | Anubis Barcelona Regul Oil | Propylene Glycol, Panthenol, Thiamine HCL |
| 83021-742 | Anubis Barcelona Regul Oil | Cetearyl Ethylhexanoate, Propylene Glycol, Glyceryl Stearate Se |