Label: ANUBIS BARCELONA REGUL OIL- peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrate
- NDC Code(s): 83021-624-10
- Packager: ANUBIS COSMETICS SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 1, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA REGUL OIL
peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrateProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 3.512 mL in 10 mL POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL 0.04 g in 10 mL YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED 0.0345 g in 10 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 0.0138 g in 10 mL ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 0.00007 g in 10 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.025 g in 10 mL POWDERED CELLULOSE (UNII: SMD1X3XO9M) (POWDERED CELLULOSE - UNII:SMD1X3XO9M) POWDERED CELLULOSE 0.0006 g in 10 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN 0.0000002 g in 10 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.000002 g in 10 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.02 g in 10 mL ETHYLPARABEN (UNII: 14255EXE39) (ETHYLPARABEN - UNII:14255EXE39) ETHYLPARABEN 0.0000003 g in 10 mL ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE 0.0001 g in 10 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 6.2503117 mL in 10 mL TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE 0.02 g in 10 mL LEVOMENOL (UNII: 24WE03BX2T) (LEVOMENOL - UNII:24WE03BX2T) LEVOMENOL 0.009 g in 10 mL HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) (HYDROXYETHYL CELLULOSE, UNSPECIFIED - UNII:T4V6TWG28D) HYDROXYETHYL CELLULOSE, UNSPECIFIED 0.034 g in 10 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.0012 g in 10 mL FARNESOL (UNII: EB41QIU6JL) (FARNESOL - UNII:EB41QIU6JL) FARNESOL 0.001 g in 10 mL METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN 0.0100013 g in 10 mL PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.005 g in 10 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.000006 g in 10 mL BUTYLPARABEN (UNII: 3QPI1U3FV8) (BUTYLPARABEN - UNII:3QPI1U3FV8) BUTYLPARABEN 0.0000005 g in 10 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.0002 g in 10 mL RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 0.000006 g in 10 mL CITRAL (UNII: T7EU0O9VPP) (CITRAL - UNII:T7EU0O9VPP) CITRAL 0.000194 g in 10 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)- 0.00419 g in 10 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 5 0.00002 g in 10 mL Inactive Ingredients Ingredient Name Strength THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.0006 g in 10 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.005 g in 10 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.0001 g in 10 mL VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.000098 g in 10 mL SODIUM ACETATE (UNII: 4550K0SC9B) 0.003 g in 10 mL EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.01 g in 10 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-624-10 10 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 10/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 10/21/2022 07/07/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-624)
