Label: ACNE FIGHTING FOUNDATION CARAMEL- salicylic acid cream

  • NDC Code(s): 70412-435-01
  • Packager: Zhejiang Ayan Biotech Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredients

    Salicylic Acid 0.5%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Helps prevent new acne blemishes
  • Warnings

    For external use only

    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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • clear 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 (Aqua), Cyclopentasiloxane, Dimethicone, Ethoxydiglycol, Propylene Glycol, PEG-10 Dimethicone, Hydrogenated Polyisobutene, Cyclohexasiloxane, Nylon-12, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Talc, Quaternium-18 Bentonite, Magnesium Sulfate, Butylene Glycol, Aloe Barbadensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cinnamomum Camphora (Camphor) Bark Oil, Glycerin, Palmitoyl Hexapeptide-12, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, MAY CONTAIN: Titanium Dioxide (CI 77891), Red Iron Oxide (CI 77491), Yellow Iron Oxide (CI 77492), Black Iron Oxide (CI 77499)

  • Questions or comments?

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  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    ACNE FIGHTING FOUNDATION CARAMEL 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-435
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    NYLON-12 (UNII: 446U8J075B)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TALC (UNII: 7SEV7J4R1U)  
    BENTOQUATAM (UNII: 7F465U79Q1)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70412-435-011 in 1 BOX11/01/2018
    136 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/01/2018
    Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co.,Ltd.544377996manufacture(70412-435)
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