Label: 10% AZELAIC ACID ACNE CREAM cream

  • NDC Code(s): 84148-009-01
  • Packager: Guangzhou Ariel Biotech Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 29, 2024

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  • Active Ingredient(s)

    AZELAIC ACID 10.00000%

    HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID 0.50000%

    CAPRYLOYL GLYCINE 0.15000%

    o-CYMEN-5-OL 0.09000%

    MADECASSOSIDE 0.05500%

    CENTELLA ASIATICA EXTRACT 0.03000%

    LAVANDULA HYBRIDA OIL 0.03000%

    ASIATICOSIDE 0.01500%

    SAURURUS CHINENSIS LEAF/ROOT EXTRACT 0.01000%

    TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT 0.01000%

    STEPHANIA TETRANDRA EXTRACT 0.00160%

  • Purpose

    Acne treatment

    ①Treatments for acne.
    ②Reduces acne and blemishes.
    ③Evens skin tone & fades spots.
    ④Balances oil & prevents breakouts.

  • Use

    Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use
    sunscreen during the day.

  • Warnings

    WARNINGS:For external use only. avoid the eye area. Avoid direct sunlight during use.
    Discontinue use immediately if rritation occurs. Store in a cool, dry place.

  • Do not use

    Stop using immediately if there is any stimulation

  • WHEN USING

    Discontinve use if any irritation or adverse reaction occurs.

  • STOP USE

    For external use only, avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if rritation occurs. Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.

  • Other information

    No Data

  • Inactive ingredients

    WATER, AZEL AIC ACID, BUTYLENE GLYCOL, METHYLPROPANEDIOL, DIMETHICONE, CETEARYL GLUCOSIDE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, POLYACRYLATE-6, SQUAL ANE, CETYL ALCOHOL, HYDROXYPROPYL CYCLODEXTRIN, 1,2-HEXANEDIOL, 4-HYDROXYACETOPHENONE, HYDROXYETHYLPIPERAZINEETHANE SULFONIC ACID, STEARYL ALCOHOL, ALLANTOIN, CYCLODEXTRIN, CAPRYLOYL GLYCINE, XANTHAN GUM, O-CYMEN-5-OL, MADECASSOSIDE, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA OL, CENTELLA ASIATICA, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, TARAXACUM OFFICINALE LEAF EXTRACT, STEPHANIA TETRANDRAE EXTRACT

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    10% AZELAIC ACID ACNE CREAM 
    10% azelaic acid acne cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84148-009
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASIATICOSIDE (UNII: PKO39VY215) (ASIATICOSIDE - UNII:PKO39VY215) ASIATICOSIDE0.015 g  in 100 g
    MADECASSOSIDE (UNII: CQ2F5O6YIY) (MADECASSOSIDE - UNII:CQ2F5O6YIY) MADECASSOSIDE0.055 g  in 100 g
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) (CENTELLA ASIATICA TRITERPENOIDS - UNII:4YS74Q4G4J) CENTELLA ASIATICA TRITERPENOIDS0.03 g  in 100 g
    LAVANDIN OIL (UNII: 9RES347CKG) (LAVANDIN OIL - UNII:9RES347CKG) LAVANDIN OIL0.03 g  in 100 g
    AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID10 g  in 100 g
    O-CYMEN-5-OL (UNII: H41B6Q1I9L) (O-CYMEN-5-OL - UNII:H41B6Q1I9L) O-CYMEN-5-OL0.09 g  in 100 g
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) (CAPRYLOYL GLYCINE - UNII:8TY5YO42NJ) CAPRYLOYL GLYCINE0.15 g  in 100 g
    HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I) (HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID - UNII:RWW266YE9I) HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID0.5 g  in 100 g
    TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y) (TARAXACUM OFFICINALE LEAF - UNII:0022LFJ74Y) TARAXACUM OFFICINALE LEAF0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84148-009-0130 g in 1 BOTTLE; Type 0: Not a Combination Product09/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/29/2024
    Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ariel Biotech Co., Ltd.402818771manufacture(84148-009)
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