AZELAQ- salicylic acid gel

Azelaq by

Drug Labeling and Warnings

Azelaq by is a Otc medication manufactured, distributed, or labeled by METHODIQ INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Salicylic Acid 0.5%

Purpose

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

Uses

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

Warnings

For external use only

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.

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

Directions

• 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

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.

PRINCIPAL DISPLAY PANEL

15ml

0.5 Fl. Oz.

Azelaq

Salicylic Acid Acne Treatment

INGREDIENTS AND APPEARANCE

AZELAQ 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87110-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
UREA (UNII: 8W8T17847W)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ALLANTOIN (UNII: 344S277G0Z)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
THREONINE (UNII: 2ZD004190S)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
LYSINE HCL (UNII: JNJ23Q2COM)
3-HEXENOL (UNII: V14F8G75P4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
QUATERNIUM-73 (UNII: 5X73DDS97A)
PROLINE (UNII: 9DLQ4CIU6V)
BETAINE (UNII: 3SCV180C9W)
PHENETHYL ALCOHOL (UNII: ML9LGA7468)
CELLULOSE GUM (UNII: K679OBS311)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
4-T-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
PROPANEDIOL (UNII: 5965N8W85T)
AZELAIC ACID (UNII: F2VW3D43YT)
SODIUM PCA (UNII: 469OTG57A2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
ALANINE (UNII: OF5P57N2ZX)
GLUTAMIC ACID (UNII: 3KX376GY7L)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GAMMA-UNDECALACTONE (UNII: QB1T0AG2YL)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOMER (UNII: 0A5MM307FC)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SERINE (UNII: 452VLY9402)
CITRIC ACID (UNII: 2968PHW8QP)
2,6-DIMETHYL-7-OCTEN-2-OL (UNII: 46L1B02ND9)
HELIOTROPINE (UNII: KE109YAK00)
ALPHA-ARBUTIN (UNII: 72VUP07IT5)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ARGININE (UNII: 94ZLA3W45F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PCA (UNII: SZB83O1W42)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87110-003-01	1 in 1 CARTON	11/18/2025
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/18/2025

Labeler - METHODIQ INC. (119377051)