ANUBIS BARCELONA REGUL OIL- peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrate

Anubis Barcelona Regul OIl by

Drug Labeling and Warnings

Anubis Barcelona Regul OIl by is a Otc medication manufactured, distributed, or labeled by ANUBIS COSMETICS SL, GDC OF FLORIDA IMPORTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

INDICATIONS & USAGE

DO NOT USE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANUBIS BARCELONA REGUL OIL 
peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrate

Product 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)