Label: ANUBIS BARCELONA REGUL OIL (propylene glycol, glyceryl stearate se, humulus lupulus- hops cone extract cream
- NDC Code(s): 83021-300-01
- 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
propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 0.012 g in 200 mL POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) (POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) - UNII:RHA9LWJ494) POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) 0.8 g in 200 mL LAURETH-7 (UNII: Z95S6G8201) (LAURETH-7 - UNII:Z95S6G8201) LAURETH-7 0.12 g in 200 mL PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE) (PEG/PPG-20/6 DIMETHICONE - UNII:PWZ7N4UIKE) PEG/PPG-20/6 DIMETHICONE 1.372 g in 200 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.08 mL in 200 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.048 g in 200 mL CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE 4 g in 200 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)- 0.08398 g in 200 mL PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.1 g in 200 mL IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA 0.6 g in 200 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 5 0.00004 g in 200 mL RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 0.00012 g in 200 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 0.0252 g in 200 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.6 g in 200 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 123.55598 mL in 200 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) (CETOSTEARYL ALCOHOL - UNII:2DMT128M1S) CETOSTEARYL ALCOHOL 26 g in 200 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 10.148 g in 200 mL MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 6 g in 200 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN 0.0028 g in 200 mL METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) (METHYLCHLOROISOTHIAZOLINONE - UNII:DEL7T5QRPN) METHYLCHLOROISOTHIAZOLINONE 0.045 g in 200 mL METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE 0.15 g in 200 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 0.0012 g in 200 mL TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE 0.3 g in 200 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN 0.24 g in 200 mL YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED 0.023 g in 200 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.023 g in 200 mL C13-14 ISOPARAFFIN (UNII: E4F12ROE70) (C13-14 ISOPARAFFIN - UNII:E4F12ROE70) C13-14 ISOPARAFFIN 0.48 g in 200 mL METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN 0.48 g in 200 mL GLYCERYL STEARATE SE (UNII: FCZ5MH785I) (GLYCERYL STEARATE SE - UNII:FCZ5MH785I) GLYCERYL STEARATE SE 7 g in 200 mL TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) (TRIISOPROPANOLAMINE - UNII:W9EN9DLM98) TRIISOPROPANOLAMINE 0.004 g in 200 mL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) (PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) - UNII:255PIF62MS) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 0.0012 g in 200 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.1 g in 200 mL SODIUM SULFATE (UNII: 0YPR65R21J) 0.9 g in 200 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00024 g in 200 mL MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 4 g in 200 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00024 g in 200 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.002 g in 200 mL SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12.6 g in 200 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.045 g in 200 mL MAGNESIUM NITRATE (UNII: 77CBG3UN78) 0.045 g in 200 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.012 g in 200 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-300-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 10/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 10/20/2022 02/03/2028 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-300)
