Label: AAPE HAIR AMPOULE- panthenol liquid

  • 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 May 28, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Panthenol 0.5%

  • INACTIVE INGREDIENT

    [Powder] MANNITOL, Human Adipose Derived Mesenchymal Cell Exosomes.

    [Solvent] Water, Alcohol, Propylene Glycol, Glycerin, Lactic Acid, Hydroxyacetophenone, Propanediol, Polyquaternium-7, Niacinamide, Polysorbate 20, Butylene Glycol, Caprylhydroxamic Acid, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Sodium Benzoate

  • PURPOSE

    Hair elasticity

  • 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. Keep in the refrigerator at 2-6°C.
    5. Keep out of reach of children.
    6. Avoid direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    ■ Improves effects of hair elasticity.

  • Directions

    Gently mix with AAPE powder to dissolve the mixture.
    Take proper amount and gently apply onto the scalp

  • QUESTIONS

    www.prostemics.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    AAPE HAIR AMPOULE 
    panthenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62041-330-026 in 1 CARTON05/01/2021
    1NDC:62041-330-016 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2021
    Labeler - PROSTEMICS Co., Ltd. (689605919)
    Registrant - PROSTEMICS Co., Ltd. (689605919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prostemics Co., Ltd. Factory695687674manufacture(62041-330)