FDA.reportPublic FDA data

Azelaq

Manufacturer
METHODIQ INC.
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:16:40

Label at a glance#

ProductAzelaq
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

For the management / treatment of acne. Clears acne blemishes and blackheads. Helps prevent the development of new acne blemishes and blackheads.

Dosage and administration

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Salicylic Acid 0.5%..............Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the management / treatment of acne.
  • Clears acne blemishes and blackheads.
  • Helps prevent the development of new acne blemishes and blackheads.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propanediol, Cetearyl Alcohol, Arginine, Aloe Barbadensis Leaf Juice, Azelaic Acid, Dimethicone, Isododecane, Methylpropanediol, Carbomer, Sodium PCA, Phenoxyethanol, Pentylene Glycol, Sodium Polyacrylate, Butylene Glycol, Microcrystalline Cellulose, Dimethicone Crosspolymer, Potassium Sorbate, Allantoin, Sphingomonas Ferment Extract, Alpha-Arbutin, Dipotassium Glycyrrhizate, Glycerin, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Ethylhexylglycerin, Betaine, Cellulose Gum, 4-t-Butylcyclohexanol, Hydroxyphenyl Propamidobenzoic Acid, Hydroxypropyltrimonium Hyaluronate, Urea, Sodium Hydroxide, Sodium Lactate, PCA, Trehalose, Polyquaternium-51, Serine, Alanine, Glycine, Citric Acid, Sodium Hyaluronate, Glutamic Acid, Lysine HCl, Threonine, Sodium Benzoate, Ascorbyl Palmitate, Quaternium-73, Proline, Triethyl Citrate, Phenethyl Alcohol, 2,6-Dimethyl-7-Octen-2-ol, Benzyl Acetate, Heliotropine, 3-Hexenol, Gamma-Undecalactone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15ml

0.5 Fl. Oz.

Azelaq

Salicylic Acid Acne Treatment

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN1
252296salicylic acid 0.005 MG/MG Topical GelSCD1
252296salicylic acid 0.5 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1287290110983949Azelaq Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87110-003-01Azelaq15 mL in 1 BOTTLE, PUMPGEL151
87110-003-01Azelaq1 in 1 CARTONGEL11

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87110-00387110-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
BENZYL ACETATE0ECG3V79ZJIACT
UREA8W8T17847WIACT
TREHALOSEB8WCK70T7IIACT
SODIUM LACTATETU7HW0W0QTIACT
PENTYLENE GLYCOL50C1307PZGIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ALLANTOIN344S277G0ZIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
THREONINE2ZD004190SIACT
WATER059QF0KO0RIACT
GLYCINETE7660XO1CIACT
LYSINE HCLJNJ23Q2COMIACT
3-HEXENOLV14F8G75P4IACT
SALICYLIC ACIDO414PZ4LPZACTIB
SODIUM BENZOATEOJ245FE5EUIACT
QUATERNIUM-735X73DDS97AIACT
PROLINE9DLQ4CIU6VIACT
BETAINE3SCV180C9WIACT
PHENETHYL ALCOHOLML9LGA7468IACT
CELLULOSE GUMK679OBS311IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
4-T-BUTYLCYCLOHEXANOLK0H1405S9CIACT
PROPANEDIOL5965N8W85TIACT
AZELAIC ACIDF2VW3D43YTIACT
SODIUM PCA469OTG57A2IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
ALANINEOF5P57N2ZXIACT
GLUTAMIC ACID3KX376GY7LIACT
ASCORBYL PALMITATEQN83US2B0NIACT
GAMMA-UNDECALACTONEQB1T0AG2YLIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CARBOMER0A5MM307FCIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ISODODECANEA8289P68Y2IACT

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
AzelaqSALICYLIC ACIDMETHODIQ INC.43084456-e452-07d9-e063-6294a90a36c82025-11-10WarningsExact identifier
ndc (package): 87110-003-01
ndc (product): 87110-003
ndc11 (package): 87110000301
spl id: 43084456-e453-07d9-e063-6294a90a36c8
spl set id: 43084456-e452-07d9-e063-6294a90a36c8

Reported adverse events (FAERS/openFDA)#

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