Label: ELF COLOR- p-phenylenediamine cream

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

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Drug Label Information

Updated September 5, 2015

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  • ACTIVE INGREDIENT

    p-phenylenediamine 2%

  • PURPOSE

    Hair Coloring

  • INDICATIONS & USAGE

    Shampoo and dry hair before use
    Apply the first solution and keep it on hair for 10 minutes (Adjust the time ±5-10 minutes if needed)
    Rinse completely and dry hair
    Apply second solution and rinse thoroughly till water runs clear and then shampoo and condition

  • DOSAGE & ADMINISTRATION

    Shampoo and dry hair before use
    Apply the first solution and keep it on hair for 10 minutes (Adjust the time ±5-10 minutes if needed)
    Rinse completely and dry hair
    Apply second solution and rinse thoroughly till water runs clear and then shampoo and condition

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Cetyl Alcohol, Cetrimonium Chloride, Propylene Glycol, Cellulose Gum, Cocamidopropyl Betaine, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Dipotassium Glycyrrhizate, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ELF COLOR 
    p-phenylenediamine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70072-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    P-PHENYLENEDIAMINE (UNII: U770QIT64J) (P-PHENYLENEDIAMINE - UNII:U770QIT64J) P-PHENYLENEDIAMINE9.58 g  in 479.39 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70072-002-021 in 1 CARTON09/05/2015
    1NDC:70072-002-01479.39 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2015
    Labeler - giod Co. (689514993)
    Registrant - giod Co. (689514993)
    Establishment
    NameAddressID/FEIBusiness Operations
    giod Co.689514993manufacture(70072-002)
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