FDA.reportPublic FDA data

14% Azelaic Acid Acne

Manufacturer
Guangdong Bisutang Biotechnology Co., Ltd.
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:52

Label at a glance#

Product14% Azelaic Acid Acne
Active ingredientAZELAIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

WATER
GLYCERIN
PROPYLENE GLYCOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
DIMETHICONE
HYDROGENATED POLYDECENE
POTASSIUM CETYL PHOSPHATE
POLYACRYLATE CROSSPOLYMER-6
METHYLPROPANEDIOL
HYDROXYACETOPHENONE
POLYACRYLAMIDE
ALLANTOIN
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
C13-14 ISOPARAFFIN
ISOHEXADECANE
XANTHAN GUM
DISODIUM EDTA
SODIUM HYALURONATE
CAPRYLHYDROXAMIC ACID
POLYSORBATE 80
LAURETH-7
DIPOTASSIUM PHOSPHATE
SORBITAN OLEATE
GLYCERYL CAPRYLATE

DOSAGE & ADMINISTRATION SECTION

30g,

Cleanse the skin thoroughly before applying.Apply a thin layer to affected area and gently massage until fully absorbed.Use once or
twice daily,or as directed by a doctor

WARNINGS SECTION

Warnings:For external use only
Avoid contact with eyes and mucous membranes.Mild irritation,redness.or dryness may occur.Stop use and ask a doctor if severe irritation occurs or if symptoms worsen.Do not use on broken or irritated skin or if allergic to any ingredient.lf pregnant or breast-feeding,ask a health professional before use.Keep out of reach of children.If swallowed,get medical help right away.

OTC - ACTIVE INGREDIENT SECTION

Azelaic Acid

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children,If swallowed,get medical help rightaway

OTC - PURPOSE SECTION

Acne treatment

INDICATIONS & USAGE SECTION

Uses: Helps treat acne and reduce the appearance of blemishes.Helps improve uneven-looking skin tone caused by acne.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label imageLabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2738813azelaic acid 14 % Topical CreamPSN1
2738813azelaic acid 140 MG/ML Topical CreamSCD1
2738813azelaic acid 14 % Topical CreamSY1

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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84753-056-0114% Azelaic Acid Acne30 g in 1 BOTTLECREAM301

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84753-05684753-056-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
SODIUM HYALURONATEYSE9PPT4THIACT
WATER059QF0KO0RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
LAURETH-7Z95S6G8201IACT
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
XANTHAN GUMTTV12P4NEEIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
AZELAIC ACIDF2VW3D43YTACTIB
GLYCERINPDC6A3C0OXIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)RHA9LWJ494IACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
ISOHEXADECANE918X1OUF1EIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITAN OLEATE06XEA2VD56IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT

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
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsExact identifier
ndc (package): 84753-056-01
ndc (product): 84753-056
ndc11 (package): 84753005601
spl id: 4ccaa734-83bf-611b-e063-6294a90ab3bf
spl set id: 4ccaa734-83be-611b-e063-6294a90ab3bf

Reported adverse events (FAERS/openFDA)#

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