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

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.

----------

RO Roll on ingredient

RO Roll on indications

RO Roll on do not use

RO Roll on keep out of reach

RO Roll on dosage

RO Roll on warnings

RO Roll on ingredient list

RO Roll on purpose

RO Roll on display

ANUBIS BARCELONA REGUL OIL 
peg-40 hydrogenated castor oil, propylene glycol, arctium majus root extract concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-624
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.512 mL  in 10 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL0.04 g  in 10 mL
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED0.0345 g  in 10 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.0138 g  in 10 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT0.00007 g  in 10 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.025 g  in 10 mL
POWDERED CELLULOSE (UNII: SMD1X3XO9M) (POWDERED CELLULOSE - UNII:SMD1X3XO9M) POWDERED CELLULOSE0.0006 g  in 10 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN0.0000002 g  in 10 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.000002 g  in 10 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.02 g  in 10 mL
ETHYLPARABEN (UNII: 14255EXE39) (ETHYLPARABEN - UNII:14255EXE39) ETHYLPARABEN0.0000003 g  in 10 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE0.0001 g  in 10 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER6.2503117 mL  in 10 mL
TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE0.02 g  in 10 mL
LEVOMENOL (UNII: 24WE03BX2T) (LEVOMENOL - UNII:24WE03BX2T) LEVOMENOL0.009 g  in 10 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) (HYDROXYETHYL CELLULOSE, UNSPECIFIED - UNII:T4V6TWG28D) HYDROXYETHYL CELLULOSE, UNSPECIFIED0.034 g  in 10 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.0012 g  in 10 mL
FARNESOL (UNII: EB41QIU6JL) (FARNESOL - UNII:EB41QIU6JL) FARNESOL0.001 g  in 10 mL
METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN0.0100013 g  in 10 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.005 g  in 10 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.000006 g  in 10 mL
BUTYLPARABEN (UNII: 3QPI1U3FV8) (BUTYLPARABEN - UNII:3QPI1U3FV8) BUTYLPARABEN0.0000005 g  in 10 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.0002 g  in 10 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.000006 g  in 10 mL
CITRAL (UNII: T7EU0O9VPP) (CITRAL - UNII:T7EU0O9VPP) CITRAL0.000194 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. 50.00002 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-624-1010 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00610/21/202207/07/2027
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-624)

Revised: 9/2023
Document Id: 0452a0dd-b516-29ea-e063-6294a90aecca
Set id: eb905bd0-c600-b8b2-e053-2995a90ad259
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL