Label: CELLEXOSOME HE HR- niacinamide liquid

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

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Drug Label Information

Updated February 14, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: Niacinamide 3.0%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    [Powder] HUMAN ADIPOSE DERIVED STEM CELL CONDITIONED MEDIA, Asparagus Officinalis Extract
    [Solvent] Water, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Hyaluronate

  • PURPOSE

    Purpose: Hair elasticity

  • WARNINGS

    Warnings:
    For external use only
    1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product
    2. Do not apply to open wounds.
    3. Avoid contact with eyes.
    Storage and handling
    4. Replace the cap after use
    5. Keep out of reach of children.
    6. Avoid direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN SECTION

    KEEP OUT OF REACH OF CHILDREN SECTION

  • Uses

    Uses:

    Improves effects of hair elasticity.

  • Directions

    Directions:

    ■ Put solvent into the powder ampoule and shake gently enough to dissolve the mixture.
    ■ Take proper amount and gently apply onto the scalp.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CELLEXOSOME HE HR 
    niacinamide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.18 g  in 6 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Panthenol (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62041-310-021 in 1 CARTON02/01/2020
    1NDC:62041-310-016 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2020
    Labeler - PROSTEMICS Co., Ltd. (689605919)
    Registrant - PROSTEMICS Co., Ltd. (689605919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prostemics Co., Ltd. Factory695687674manufacture(62041-310)
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