Label: DR.ALTHEA POWER WHITENING GLUTATHIONE- niacinamide 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 August 12, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    NIACINAMIDE

  • INACTIVE INGREDIENT

    Water,Butylene Glycol,Glycerin,Dimethicone,Panthenol,Titanium Dioxide (CI 77891),Niacinamide,Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glutathione, Cyclopentasiloxane,Isohexadecane,Sodium Polyacrylate,Ethylhexyl Stearate,Polysorbate 80,Dimethiconol,Betaine,Triethoxycaprylylsilane,Trideceth-6,Pantolactone,Disodium EDTA,Phenoxyethanol,Chlorphenesin,Caprylyl Glycol,Ethylhexylglycerin,Fragrance

  • PURPOSE

    Helps skin whitening

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Take appropriate amount and apply evenly to skin

  • WARNINGS

    1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
    1) Occurrence of red spots, swelling, itchiness, and other skin irritation
    2) If the symptoms above occur after the application area is exposed to direct sunlight
    2. Do not use on open wounds, eczema, and other skin irritations
    3. Precaution for Storage and Handling
    1) Close the lid after use
    2) Keep out of reach of infants and children
    3) Do not to store in a place with high/low temperature and exposed to direct sunlight

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR.ALTHEA POWER WHITENING GLUTATHIONE 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70905-0002-150 mL in 1 JAR; Type 0: Not a Combination Product08/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/11/2016
    Labeler - Dr. Althea (689694436)
    Registrant - Dr. Althea (689694436)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Althea689694436manufacture(70905-0002)