ANUBISMED- glycolic acid, citric acid, lactic acid, kojic acid liquid 
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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ANUBISMED 
glycolic acid, citric acid, lactic acid, kojic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID17 g  in 50 mL
KOJIC ACID (UNII: 6K23F1TT52) (KOJIC ACID - UNII:6K23F1TT52) KOJIC ACID2.5 g  in 50 mL
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N) HEXYLRESORCINOL1 g  in 50 mL
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) (ASCORBYL GLUCOSIDE - UNII:2V52R0NHXW) ASCORBYL GLUCOSIDE0.25 g  in 50 mL
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID5 g  in 50 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.225 g  in 50 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.5 g  in 50 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) (HYDROXYETHYL CELLULOSE, UNSPECIFIED - UNII:T4V6TWG28D) HYDROXYETHYL CELLULOSE, UNSPECIFIED0.34875 g  in 50 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL6.3 mL  in 50 mL
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA2.75 g  in 50 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 g  in 50 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER7.333 mL  in 50 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.025 g  in 50 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 5 g  in 50 mL
SODIUM NITRATE (UNII: 8M4L3H2ZVZ) 0.01875 g  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-401-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00611/04/202207/01/2027
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-401)

Revised: 9/2023
Document Id: 049fdc9c-b52f-63c1-e063-6394a90aaa6a
Set id: eca95dde-cb57-2ab6-e053-2995a90af84f
Version: 2
Effective Time: 20230905
 
ANUBIS COSMETICS SL