Label: NUVILEO SKIN PERFECTING ACNE- salicylic acid cream

  • 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 July 15, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    for treatment of acne

  • Warnings

    for external use only

    Ask a doctor if you are using other topical acne medications at the same time or immediately following use of this product. If increased dryness or irritation occurs, only one medication should be used, unless directed by a doctor.

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

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Apply thin layer of cream on affected skin surface.

  • Inactive ingredients

    Allantoin, Aloe Barbadensis Leaf, Aloe barbadensis mill, C13-14 Isoparaffin, Caprylyl Glycol, Citrus Grandis (Grapefruit) Peel Oil, Cyclomethicone, Disodium EDTA, Emulsifying Wax, Ethylhexyl Stearate, Hydrastis canadensis L., Laureth-7, Olea Europaea (Olive) Fruit Oil, Panax quinquefolius L., Passiflora Incarnata, Phenoxyethanol, Polyacrylamide, Purified Water, Sorbitol, Tocopheryl Acetate, Triethanolamine

  • PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

    Nuviléo™

    Skin Perfecting
    Acne Cream

    Residue free acne cream for
    Clear Skin Everyday

    • Reduces redness
    • Clears breakouts
    • Hydrates, soothes & repairs

    Salicylic Acid Acne Treatment

    2 FL. OZ. / 60 ml.

    Principal Display Panel - 60 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    NUVILEO SKIN PERFECTING ACNE 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Aloe Vera Whole (UNII: KIZ4X2EHYX)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    Hydrastis Canadensis Whole (UNII: R763EBH88T)  
    Laureth-7 (UNII: Z95S6G8201)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Panax Quinquefolius Whole (UNII: 0P067WOA1X)  
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-500-0260 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/30/2015
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs 032973000MANUFACTURE(58133-500)
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