Label: 10% AZELAIC ACID- azelaic acid cream cream
14% AZELAIC ACID- azelaic acid cream

  • NDC Code(s): 87815-002-01, 87815-003-01
  • Packager: Guangzhou Ariel Medical Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 3, 2026

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Directions

    Cleanse face to remove dirt and impurities.

    Wash face and gently pat dry.

    Dispense cream onto hands and apply directly to acne-prone areas.

    Use twice daily (morning and evening).

  • INDICATIONS & USAGE

    For the treatment of acne.

  • ACTIVE INGREDIENT

    Azelaic Acid 10%

  • PURPOSE

    Acne Treatment

  • WARNINGS

    For external use only.

  • DO NOT USE

    on broken skin; if allergic to any ingredients.

  • ASK DOCTOR

    Ask a doctor before use if: pregnant or nursing, or have any underlying medical condition.

  • WHEN USING

    When using this product: avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if: significant facial swelling, large areas of red rash, intense itching or burning sensation.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: if swallowed, get medical help or contact Poison Control Center right away.

  • OTHER SAFETY INFORMATION

    Store at room temperature (10°C–25°C). Do not expose to temperatures above 45°C. Keep away from light.

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Methylpropandiol, Dimethicone, Cetearyl Glucoside, Dipropylene Glycol, Sorbitan Olivate, Polyacrylate-6, Squalane, Cetyl Alcohol, Hydroxypropyl Cyclodextrin, 1,2-Hexanediol, 4-Hydroxyacetophenone, Hydroxyethylpiperazineethan Sulfate, Allantoin, Cyclodextrin, Caprylyl Glycine, Xanthan Gum, O-Cymene-5-ol, Madecassoside, Centella Asiatica Extract, Lavandula Angustifolia Oil, Centella Asiatica, Saurus Chinensis Leaf/Root Extract, Taraxacum Officinale Leaf Extract, Stephania Tetrandrae Extract.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Ariel Biotech Inc

    1226 NORTH KING ST.NUM 968
    WILMINGTON, DE 19801
    USA

  • PRINCIPAL DISPLAY PANEL

    14Azelaic Acid10Azelaic Acid

  • INGREDIENTS AND APPEARANCE
    10% AZELAIC ACID 
    azelaic acid cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:87815-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SQUALANE (UNII: GW89575KF9)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLICAPRAM (UNII: 14GUK8I73Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    STEPHANIA TETRANDRA ROOT (UNII: 48PS81XHK0)  
    O-CYMENE (UNII: 2T13HF3266)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:87815-002-0130 g in 1 TUBE; Type 0: Not a Combination Product07/03/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/03/2026
    14% AZELAIC ACID 
    azelaic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:87815-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y)  
    4-HYDROXY-1-NAPHTHALENESULFONIC ACID (UNII: 6W41U3C9YN)  
    WATER (UNII: 059QF0KO0R)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLICAPRAM (UNII: 14GUK8I73Z)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CYCLODEXTRIN (UNII: 7E6SK9QDT8)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SQUALANE (UNII: GW89575KF9)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    STEPHANIA TETRANDRA ROOT (UNII: 48PS81XHK0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:87815-003-0130 g in 1 TUBE; Type 0: Not a Combination Product07/03/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/03/2026
    Labeler - Guangzhou Ariel Medical Technology Co., Ltd. (554475230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ariel Medical Technology Co., Ltd.554475230manufacture(87815-002, 87815-003)