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
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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)
