Label: AAPE SKIN AMPOULE- niacinamide liquid

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

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Drug Label Information

Updated August 26, 2019

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  • ACTIVE INGREDIENT

    Active ingredients: Niacinamide 2.00% 

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Butylene Glycol, Glycerin, Sorbitol, Hydroxyacetophenone, Propanediol, Xanthan Gum, Allantoin, Adenosine, Caprylhydroxamic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-5

  • PURPOSE

    Purpose: Skin Brightening

  • 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. 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

    Uses:

    Helps brighten skin tone.

  • Directions

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    AAPE SKIN AMPOULE 
    niacinamide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.12 g  in 6 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62041-250-016 mL in 1 CONTAINER; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2019
    Labeler - PROSTEMICS Co., Ltd. (689605919)
    Registrant - PROSTEMICS Co., Ltd. (689605919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prostemics Co., Ltd. Factory695687674manufacture(62041-250)
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