Label: AAPE CONTINUOUS RENEWAL MASK- niacinamide patch

  • 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 August 26, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients: Niacinamide 2.00% 

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Glycerin, Butylene Glycol, Human Adipocyte Conditioned Media Extract, 1,2-Hexanediol, Sorbitol, Alcohol, Xanthan Gum, Caprylyl Glycol, Glycosyl Trehalose, PEG-60 Hydrogenated Castor Oil, Hydrogenated Starch Hydrolysate, Ascorbyl Glucoside, Allantoin, Hydroxyethylcellulose, Tromethamine, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Carbomer, Adenosine, Disodium EDTA, Dipotassium Glycyrrhizate, Panthenol, Glyceryl Citrate/Lactate/Linoleate/Oleate, Sodium Hyaluronate, Olea Europaea (Olive) Fruit Oil, Polysorbate 60, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Hydrolyzed Collagen, Palmitoyl Tripeptide-5, Acetyl Hexapeptide-8, Fragrance

  • 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 out of reach of children.
    5. Avoid direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Helps brighten skin tone.

  • Directions

    Directions:

    1. After washing your face, arrange your skin texture with toner.
    2. Take out the mask sheet and put it on your entire face except around the eyes and lips.
    3. Take off the sheet 10~15 min. later and tap it gently to let the remaining essence be absorbed into the skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    AAPE CONTINUOUS RENEWAL MASK 
    niacinamide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.60 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62041-240-0130 mL in 1 POUCH; 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(62041-240)