Label: BIBOYA AZELAIC ACID TEA TREE ACNE CREAM- acne cream cream

  • NDC Code(s): 84507-005-01
  • Packager: Guangdong Miaolian Cosmetics Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 15, 2024

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  • DOSAGE & ADMINISTRATION

    1.Cleanse the skin thoroughly before applying the product
    2.Apply to affected areas with a thin layer, one to three timesdaily or as directed by a doctor

  • WARNINGS

    For external use only

  • INACTIVE INGREDIENT

    Water,1,3-propanediol, dextrin, triethyl, acrylates /C10-30 alkyl acrylate crosslinked polymer, panthenol, tocopherol acetate, urea, C13-14 iso-alkanes,ethyl hexyl glycerol, lauryl ether 7, EDTA Disodium,Sesame amino acids, Xanthan gum, bifida yeast fermentation product filtrate, 1,2-pentanediol, 1,2-hexanediol, Bacillus clostridium/Soybean fermentation product extract, folic acid, yeast fermentation product extract

  • INDICATIONS & USAGE

    Acne Treatment

    1,Treats and controls symptoms of Acne
    2,Reduces redness and inflammation associated with Acne
    3,Promotes even skin tone
    4,Minimizes the appearance of blood vessels

  • KEEP OUT OF REACH OF CHILDREN

    lf swallowed, get medical help orcontact Poison Control Center right away.

  • WHEN USING

    Avoid contact with eyes, If contact occurs,rinse eyes thoroughly with water

  • PURPOSE

    Acne Treatment

  • PRINCIPAL DISPLAY PANEL

    Package Design

  • INGREDIENTS AND APPEARANCE
    BIBOYA AZELAIC ACID TEA TREE ACNE CREAM 
    acne cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84507-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.197 mg  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.28 mg  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 mg  in 100 g
    AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID0.2 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    BIFIDOBACTERIUM BIFIDUM (UNII: WN5C16297P)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    YEAST (UNII: 3NY3SM6B8U)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHYLSILANE (UNII: 0F9429873L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    UREA (UNII: 8W8T17847W)  
    FOLIC ACID (UNII: 935E97BOY8)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    BACILLUS AMYLOLIQUEFACIENS (UNII: 1M5Y26M37U)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DEXTRIN, CORN (UNII: VAD2K35XAJ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84507-005-0120 g in 1 TUBE; Type 0: Not a Combination Product08/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/16/2024
    Labeler - Guangdong Miaolian Cosmetics Co., Ltd. (707598469)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Miaolian Cosmetics Co., Ltd.707598469label(84507-005) , manufacture(84507-005)
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