Label: ELF CONCELER PENCIL AND BRUSH- salicylic acid paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 18, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Salicylic Acid 2.0%

  • PURPOSE

    Purpose:

    Anti-Acne

  • INDICATIONS & USAGE

    Uses:

    • Conceal and heal acn for on the spot treatment
    • Medicated formula with active salicylic acid and tea tree oil heels and clears blemishes
    • Provides natural looking coverage under or above makeup so blemishes disappear
  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product:

    Avoid using other topical products on the same area unless otherwise directed by your doctor

    Avoid using salicylic acid on wounds or on areas of eczema

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

  • ASK DOCTOR

    Tell Your Doctor And Pharmacist If

    You are allergic to salicylic acid or any other medications

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children:

    If swallowed get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions:

    Use the conceal side of the pencil to cover up any unwanted blemishes and imperfections. Use the blend brush to work the formula into the skin to create a beautiful and even coverage.

  • STORAGE AND HANDLING

    Other Information:

    Store at room temperature 20-25C (68-77F)

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Synthetic Beeswax, Microstalline Wax, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Castor Oil, Ethylhexy Palmitate, Paraffinium Liquidum (Mineral Oil), Bis-Diglyceryl Polyacyladipate-2, Isopropyl Myristate, Petrolatum, Mica, Melaleuca Alternafolia (Tea Tree) Leaf Oil, BHT, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.

    May Contain:

    Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide
  • PRINCIPAL DISPLAY PANEL

    lablabel

  • INGREDIENTS AND APPEARANCE
    ELF CONCELER PENCIL AND BRUSH 
    salicylic acid paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V) 15 g  in 100 g
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MICA (UNII: V8A1AW0880)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52664-009-011.95 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/01/2010
    Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture
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