Label: CLEAR-N-SMOOTH ULTIMATE cream

  • NDC Code(s): 76445-0411-4
  • Packager: Hawknad Manufacturing Industries, Inc.
  • Category: COSMETIC
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

Drug Label Information

Updated February 17, 2015

If you are a consumer or patient please visit this version.

  • FRONT OF LABEL

    Clear-N-Smooth Ultimate

    Skin Lightening Cream

    with Vitamin E and Sunscreen

  • ACTIVE INGREDIENTS

    Hydroquinone -2.0 %, Purpose - Skin Bleaching Agent

    Octinoxate - 2.5%, Purpose - Sunscreen

  • USES

    • Lightens dark discolorations in the skin such as freckles, age and liver spots
    • Contains a sunscreen to help prevent darkening from reoccurring
  • WARNINGS AND PRECAUTIONS

    For external use only

    Do not use

    • On children under 12 years of age unless directed by a doctor
    • This product is not for use in the prevention of sunburn

    When using this product

    • Avoid contact with eyes
    • Some users of this product may experience a mild skin irritation.  If irritation becomes severe, stop use and consult a doctor.
  • INSTRUCTIONS FOR USE

    • Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor.  If no improvement is seen after 3 months of treatment, use of the product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
    • Children under 12 years of age: do not use unless directed by a doctor
    • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin after treatment is completed in order to prevent darkening from reoccurring.
  • INACTIVE INGREDIENT

    ascorbic acid, cetyl alcohol, citirc acid, chamomile, diazolidinyl urea, dimethicone, disodium EDTA, fragrance, glyceryl stearate, green tea extract, hydroxyethyl cellulose, isopropyl myristate, lanolin alcohol, licorice extract, methylparaben, propylparaben, mineral oil, peg-100 stearate, propylene glycol, sodium metabisulfite, stearyl alcohol, stearyl stearate, tocopherol acetate, water. 

  • INGREDIENTS AND APPEARANCE
    CLEAR-N-SMOOTH ULTIMATE 
    clear-n-smooth ultimate cream
    Product Information
    Product TypeCOSMETICItem Code (Source)76445-0411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) .06 g  in 1 g
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) .03 g  in 1 g
    PEG-100 STEARATE (UNII: YD01N1999R) .03 g  in 1 g
    STEARYL STEARATE (UNII: 5WX2EGD0DK) .02 g  in 1 g
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .035 g  in 1 g
    CETYL ALCOHOL (UNII: 936JST6JCN) .035 g  in 1 g
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .04 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) .03 g  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) .035 g  in 1 g
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE) .005 g  in 1 g
    DIMETHICONE 350 (UNII: 2Y53S6ATLU) .01 g  in 1 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .0025 g  in 1 g
    ETHYLHEXYL PALMITATE (UNII: 2865993309) .02 g  in 1 g
    WATER (UNII: 059QF0KO0R) .5345 g  in 1 g
    EDETATE SODIUM (UNII: MP1J8420LU) .001 g  in 1 g
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E) .005 g  in 1 g
    CHAMOMILE (UNII: FGL3685T2X) .004 g  in 1 g
    SINECATECHINS (UNII: T432289GYZ) .0025 g  in 1 g
    GLABRIDIN (UNII: HOC5567T41) .008 g  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .056 g  in 1 g
    ASCORBIC ACID (UNII: PQ6CK8PD0R) .001 g  in 1 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) .001 g  in 1 g
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) .004 g  in 1 g
    METHYLPARABEN (UNII: A2I8C7HI9T) .001 g  in 1 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) .001 g  in 1 g
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) .002 g  in 1 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    176445-0411-4118 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/02/1992
    Labeler - Hawknad Manufacturing Industries, Inc. (618892426)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hawknad Manufacturing Industries, Inc.618892426manufacture