Label: NUVILEO ACNE FACE WASH- salicylic acid solution, gel forming / drops

  • 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

    Use twice a day. Wet face, apply to hands, add water and work into a lather. Massage into your face, rinse.

  • Inactive ingredients

    Aloe Barbadensis Mill, Caprylyl Glycol, Cocamidopropyl Betaine, Coco-Glucoside, Fragrance, Glyceryl Oleate, Hydrastis canadensis L., Lauramide D A, Lauryl Gucoside, Organic Greenhouse Grown Aloe Barbadensis Leaf, Panax quinquefolis L., Phenoxyethanol, Purified Water, Sodium Citrate, Sodium Lauryl Glucose Carboxylate.

  • PRINCIPAL DISPLAY PANEL - 180 ml Bottle Label

    Nuviléo™
    Acne Face Wash

    Oil-free AM / PM cleanser for
    Clear Skin Everyday

    Non-Drying Formula

    • Reduces redness
    • Clears breakouts
    • Gently exfoliates skin
    • Removes excess oil, dirt & makeup

    Salicylic Acid Acne Treatment

    6 FL. OZ. / 180 ml.

    Principal Display Panel - 180 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    NUVILEO ACNE FACE WASH 
    salicylic acid solution, gel forming / drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-501
    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
    Aloe Vera Whole (UNII: KIZ4X2EHYX)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Coco Glucoside (UNII: ICS790225B)  
    Glyceryl Oleate (UNII: 4PC054V79P)  
    Hydrastis Canadensis Whole (UNII: R763EBH88T)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    Panax Quinquefolius Whole (UNII: 0P067WOA1X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-501-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58133-501-0390 mL in 1 BOTTLE; 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 Labs032973000MANUFACTURE(58133-501)
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