FDA.reportPublic FDA data

AnubisMed

Manufacturer
ANUBIS COSMETICS SL | GDC OF FLORIDA IMPORTS, INC.
Effective date
2023-09-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:05

Label at a glance#

ProductAnubisMed
Active ingredientAZELAIC ACID, POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, WATER, SALICYLIC ACID, ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Azelaic Peel ingredientsAzelaic Peel ingredients

INDICATIONS & USAGE SECTION

Azelaic Peel indicationsAzelaic Peel indications

OTC - DO NOT USE SECTION

Azelaic Peel do not useAzelaic Peel do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Azelaic Peel keepAzelaic Peel keep

DOSAGE & ADMINISTRATION SECTION

Azelaic Peel dosageAzelaic Peel dosage

WARNINGS SECTION

Azelaic Peel warningsAzelaic Peel warnings

INACTIVE INGREDIENT SECTION

Azelaic Peel ingredient listAzelaic Peel ingredient list

OTC - PURPOSE SECTION

Azelaic Peel purposeAzelaic Peel purpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azelaic Peel displayAzelaic Peel display

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AZELAIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-402-50AnubisMed50 mL in 1 BOTTLE, GLASSLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-402ANUBISMED (AZELAIC ACID, SALICYLIC ACID) LIQUID [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230906_ebf3153d-30f5-54e4-e053-2995a90a74b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83021-40283021-402-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
AZELAIC ACIDF2VW3D43YTACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
ALCOHOL3K9958V90MACTIB
SODIUM LACTATETU7HW0W0QTIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
ndc (package): 83021-402-50
ndc (product): 83021-402
ndc11 (package): 83021040250
spl id: 049fca13-6921-d895-e063-6294a90a42da
spl set id: ebf3153d-30f5-54e4-e053-2995a90a74b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.