Label: SALON CODE GLAM HAIR COLOR GLAM CACAO- p-aminophenol kit

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

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 September 10, 2018

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  • ACTIVE INGREDIENT

    p-Aminophenol

  • INACTIVE INGREDIENT

    ethanolamine, alcohol, butylene glycol, sodium sulfite, etc

  • PURPOSE

    hair coloring

  • KEEP OUT OF REACH OF CHILDREN

    Keep out or reach of the children

  • INDICATIONS & USAGE

    First, wear gloves before starting the coloring session. Pour an equal amount of #1(colorant) & #2(developer) into the provided plastic container and close the cap until you hear the click sound. Mix well by shaking the container horizontally or sideways until the mixture turns to gel. (Do NOT shake the container vertically or up & down). Carefully open the container from the side and scoop the contents on hand to start the procedure. Use appropriate amounts as you color by sections to apply the gel to the top, sides, and the back. Gently rub the gel against hair. With the remaining gel, lightly apply along the hairline to finish the procedure. Wait according to the indicated time for the color to process (20min. to cover gray hair). After the desired color is obtained, wash and rinse several times with lukewarm water until water runs clear. NOTE: Leave extra 10 min. for thick hair and/or if the coloring procedure is done at cool temperature (below room temperature).

  • WARNINGS

    For external use only.

    This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test should first be made. This product must not be used for dyeing of eyelashes or eyebrows. If you were to do so, it may cause blindness. When product comes in contact with eyes during the coloring session, rinse immediately with cool, running water and consult a physician immediately. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Processed color may be different from the color chart indicated on the box due to condition of individual, hair, and/or temperature. Before coloring, please read the instructions thoroughly.

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SALON CODE GLAM HAIR COLOR GLAM CACAO 
    p-aminophenol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70778-0013
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70778-0013-11 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/04/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 70 mL
    Part 21 BOTTLE 70 mL
    Part 1 of 2
    SALON CODE GLAM CACAO 
    p-aminophenol liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    P-AMINOPHENOL (UNII: R7P8FRP05V) (P-AMINOPHENOL - UNII:R7P8FRP05V) P-AMINOPHENOL0.44 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    170 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2018
    Part 2 of 2
    SALON CODE GLAM HAIR COLOR OXIDANT 
    hydrogen peroxide liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE5.845 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    170 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/04/2018
    Labeler - Daolcosmetic Co.,ltd (688279560)
    Registrant - Daolcosmetic Co.,ltd (688279560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong Sung Pharm Co., Ltd.687811661manufacture(70778-0013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daolcosmetic Co.,ltd688279560label(70778-0013)