ANUBIS BARCELONA NEW EVEN- lactic acid, citric acid, glycolic acid 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 NEW EVEN 
lactic acid, citric acid, glycolic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) (FD&C BLUE NO. 1 - UNII:H3R47K3TBD) FD&C BLUE NO. 10.0005 g  in 250 mL
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID2.348125 g  in 250 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL1.25 g  in 250 mL
TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE0.5 g  in 250 mL
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) (.ALPHA.-HEXYLCINNAMALDEHYDE - UNII:7X6O37OK2I) .ALPHA.-HEXYLCINNAMALDEHYDE0.0150375 g  in 250 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)-0.0041025 g  in 250 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID0.625 g  in 250 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL2.5 g  in 250 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID1.220625 g  in 250 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL10.5 g  in 250 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER228.15635 mL  in 250 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.75 g  in 250 mL
DEHYDROACETIC ACID (UNII: 2KAG279R6R) (DEHYDROACETIC ACID - UNII:2KAG279R6R) DEHYDROACETIC ACID0.25 g  in 250 mL
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) (DIETHYLENE GLYCOL MONOETHYL ETHER - UNII:A1A1I8X02B) DIETHYLENE GLYCOL MONOETHYL ETHER0.75 g  in 250 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.075 g  in 250 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.022755 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.47 g  in 250 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.9375 g  in 250 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-033-01250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/13/2022
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-033)

Revised: 10/2022
Document Id: eaeeb6e0-5323-20c4-e053-2995a90a9fd9
Set id: eaeeb6e0-5322-20c4-e053-2995a90a9fd9
Version: 1
Effective Time: 20221013
 
ANUBIS COSMETICS SL