Label: NEOVA COMPLEX HQ PLUS- hydroquinone emulsion

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 2, 2014

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  • INDICATIONS & USAGE

    Complex HQ Plus is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigenes, and other unwanted areas of melanin hyperpigmention.

  • DIRECTIONS:

    Apply a thin layer on the skin surface in the affected areas twice a day or as directed by physician. Use of this product should be discontinued after 3 months of treatment if no improvement is observed. The lightening effect may not be noticeable when used on very dark skin. Sun exposure should be avoided. DNA Damage Control [EVERYDAY BROAD SPECTRUM SPF 44] or other broad spectrum sunblock or protective clothing should be used to prevent reoccurring hyperpigmentation.

  • ACTIVE INGREDIENT:

    Hydroquinone, 4%

  • INACTIVE INGREDIENTS:

    Ascorbic Acid, Butylated Hydroxytoluene, Cetyl Alcohol, Edetate Disodium, Fragrance, Glycerin, Glycolic Acid, Methylparaben, Propylparaben, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, Stearyl Alcohol, Vitamin E Acetate.

  • WARNINGS:

    Avoid contact with eyes. Some users may experience mild skin irritation. If skin irritation becomes severe, stop use and consult a physician. In case of accidental ingestion, call a physician or seek a Poison Control Center immediately. Children under 12 years of age: Do not use unless directed by a physician.

  • KEEP OUT OF REACH OF CHILDREN

    FOR EXTERNAL USE ONLY.

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

  • SPL UNCLASSIFIED SECTION

    PhotoMedex, Horsham, PA 19044
    1.888.966.1010 • www.neova.com
    Made in the USA


  • Neova Complex HQ Plus2oz. (56.7 g) label and box

    ComplexHQplus2ozLabel.jpglabel ComplexHQplusBox.jpgbox

  • INGREDIENTS AND APPEARANCE
    NEOVA  COMPLEX HQ PLUS
    hydroquinone emulsion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62362-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62362-012-011 in 1 BOX
    1NDC:62362-012-0256 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2012
    Labeler - PhotoMedex, Inc. (054503875)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhotoMedex, Inc.054503875manufacture(62362-012)
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