Label: ANUBISMED- azelaic acid, salicylic acid liquid
- NDC Code(s): 83021-402-50
- 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 5, 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
ANUBISMED
azelaic acid, salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength SODIUM LACTATE (UNII: TU7HW0W0QT) 0.0035 g in 50 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-402-50 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 10/26/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 10/26/2022 09/08/2027 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-402)
