ANUBIS BARCELONA REGUL OIL- propylene glycol, panthenol, thiamine hcl lotion 
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.

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ANUBIS BARCELONA REGUL OIL 
propylene glycol, panthenol, thiamine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-740
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL52.5 mL  in 250 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.025 g  in 250 mL
TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE0.25 g  in 250 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT0.0225 g  in 250 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.0025 g  in 250 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL2 g  in 250 mL
METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN0.5 g  in 250 mL
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED0.14375 g  in 250 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 50.0015 g  in 250 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.45 g  in 250 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.5 g  in 250 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER179.89815 mL  in 250 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.05 g  in 250 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.10475 g  in 250 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.25 g  in 250 mL
CITRAL (UNII: T7EU0O9VPP) (CITRAL - UNII:T7EU0O9VPP) CITRAL0.00485 g  in 250 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL13 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00225 g  in 250 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.025 g  in 250 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.25 g  in 250 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.0025 g  in 250 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00225 g  in 250 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.015 g  in 250 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-740-01250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00610/21/202209/22/2027
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-740)

Revised: 9/2023
Document Id: 04528cb8-0159-86e0-e063-6394a90a5904
Set id: eb8e5beb-4452-58c2-e053-2a95a90a66e0
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL