Label: PERFECT ME SERUM- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 12, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    Salicyclic Acid (0.5%)
    KEY INGREDIENTS
    Azelaic Acid and Oleanolic Acid
  • PURPOSE

    PERFECT-ME SERUM
    with Salicyclic Acid
    Acne Treatment
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    PERFECT-ME SERUM LANGE
    INDICATIONS: For the Management of Acne
    This non-oily and lightely scented treatment serum has been specially formulated for acne-prone skin. With a light, fresh texture, this pleasant will contribute to:
    Help clear blackheads,
    Help prevent the development of new acne pimples,
    Allow skin to heal.

  • WARNINGS

    Not to be used for children under three years of age. Avoid contact with Eyes.
    For external use only. If skin has allergic reaction, stop use immediately.

  • DOSAGE & ADMINISTRATION

    20 ml
    0.68 FL. OZ
  • PRINCIPAL DISPLAY PANEL

    Label

  • INACTIVE INGREDIENT

    WATER
    PROPYLENE GLYCOL
    POLYMETHYL METHACRYLATE
    POTASSIUM AZELOYL DIGLYCINATE
    GLYCERIN
    CARBOMER
    OLEANOLIC ACID
    HYDROXYETHYL ACRYLATE/SODIUM
    ACRYLOYLDIMETHYLTAURATE
    COPOLYMER
    SQUALANE
    CHITOSAN SUCCINAMIDE
    XANTHAN GUM
    SALICYLIC ACID
    BUTYLENE GLYCOL
    PEG-60 ALMOND GLYCERIDES
    CAPRYLYL GLYCOL
    POLYSORBATE 60
    SODIUM LACTATE
    DISODIUM SUCCINATE
    SODIUM CITRATE
    CITRIC ACID
    BIOTIN
    BENZYL BENZOATE
    HEXYL CINNAMAL
    CITRONELLOL
    ALPHA-ISOMETHYL IONONE
    GERANIOL
    EUGENOL
    LIMONENE
    LINALOOL
    NORDIHYDROGUAIARETIC ACID
    SODIUM METABISULFITE
    CHLORPHENESIN
    PHENOXYETHANOL
    METHYLPARABEN
    SODIUM METHYLPARABEN
    BUTYLPARABEN
    ETHYLPARABEN
    PROPYLPARABEN
    ISOBUTYLPARABEN
    CI 77891 (TITANIUM DIOXIDE)
  • INGREDIENTS AND APPEARANCE
    PERFECT ME SERUM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51830-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 20 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BIOTIN (UNII: 6SO6U10H04)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    GERANIOL (UNII: L837108USY)  
    EUGENOL (UNII: 3T8H1794QW)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51830-052-0820 mg in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/18/2012
    Labeler - Lange SAS (275956105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lange SAS275956105manufacture(51830-052)