Azelaq

Azelaq
SPL v1
SPL
SPL Set ID 43084456-e452-07d9-e063-6294a90a36c8
Route
TOPICAL
Published
Effective Date 2025-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Phenoxyethanol Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Polyquaternium-51 (2-methacryloyloxyethyl Phosphorylcholine/n-butyl Methacrylate; 3:7) Benzyl Acetate Urea Trehalose Sodium Lactate Pentylene Glycol Sodium Polyacrylate (8000 Mw) Microcrystalline Cellulose Allantoin Dipotassium Glycyrrhizate Threonine Water Glycine Lysine Hcl 3-hexenol Sodium Benzoate Quaternium-73 Proline Betaine Phenethyl Alcohol Cellulose Gum Triethyl Citrate Ethylhexylglycerin 4-t-butylcyclohexanol Propanediol Azelaic Acid Sodium Pca Butylene Glycol Hydroxyphenyl Propamidobenzoic Acid Alanine Glutamic Acid Ascorbyl Palmitate Gamma-undecalactone Cetearyl Alcohol Carbomer Aloe Barbadensis Leaf Juice Isododecane Glycerin Trisodium Ethylenediamine Disuccinate Serine Citric Acid 2,6-dimethyl-7-octen-2-ol Heliotropine Alpha-arbutin Xanthan Gum Dimethicone Methylpropanediol Arginine Potassium Sorbate Pca Sodium Hyaluronate Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-18
Description

Salicylic Acid 0.5%

Purpose

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

Medication Information

Purpose

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

Description

Salicylic Acid 0.5%

Uses
  • For the management / treatment of acne.
  • Clears acne blemishes and blackheads.
  • Helps prevent the development of new acne blemishes and blackheads.
Section 50565-1

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

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.

Section 51945-4

15ml

0.5 Fl. Oz.

Azelaq

Salicylic Acid Acne Treatment

Warnings

For external use only

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.
Active Ingredients

Salicylic Acid 0.5%

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.

Structured Label Content

Uses
  • For the management / treatment of acne.
  • Clears acne blemishes and blackheads.
  • Helps prevent the development of new acne blemishes and blackheads.
Section 50565-1 (50565-1)

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

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.

Section 51945-4 (51945-4)

15ml

0.5 Fl. Oz.

Azelaq

Salicylic Acid Acne Treatment

Purpose

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

Warnings

For external use only

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.
Active Ingredients (Active ingredients)

Salicylic Acid 0.5%

Inactive Ingredients (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:15.379108 · Updated: 2026-03-14T23:10:31.490874