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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
10% AZELAIC ACID
azelaic acid cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:87815-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID 10 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:87815-002-01 30 g in 1 TUBE; Type 0: Not a Combination Product 07/03/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 07/03/2026 14% AZELAIC ACID
azelaic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:87815-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID 14 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:87815-003-01 30 g in 1 TUBE; Type 0: Not a Combination Product 07/03/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 07/03/2026 Labeler - Guangzhou Ariel Medical Technology Co., Ltd. (554475230) Establishment Name Address ID/FEI Business Operations Guangzhou Ariel Medical Technology Co., Ltd. 554475230 manufacture(87815-002, 87815-003)


