ANUBISMED- azelaic acid, salicylic 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
azelaic acid, salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83021-402
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)	AZELAIC ACID	7 g in 50 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4.9965 g in 50 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	10 g in 50 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	2.7 g in 50 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1.62 mL in 50 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g in 50 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.68 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM LACTATE (UNII: TU7HW0W0QT)	0.0035 g in 50 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83021-402-50	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/26/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	10/26/2022	09/08/2027

Labeler - ANUBIS COSMETICS SL (468680293)

Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)

Name	Address	ID/FEI	Business Operations
Establishment
ANUBIS COSMETICS SL		468680293	manufacture(83021-402)