Active Ingredients
Salicylic Acid 0.5%
Azelaq Gel
FDA Label NDC 87110-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Methodiq Inc. for the product Azelaq (NDC 87110-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - when using, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - When Using
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
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.
Package Label.Principal Display Panel
15ml
0.5 Fl. Oz.
Azelaq
Salicylic Acid Acne Treatment
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