Label: RAYDERM HYDRATING MASK- glycerin mask 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 October 11, 2018

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

  • ACTIVE INGREDIENT

    Glycerin (16%) - Skin Protectact

    Allantoin (00.5%) - Skin Protectact

  • INACTIVE INGREDIENT

    Purified Water, Dipropylene Glycol, PEG/PPG-17/6 Copolymer, Betaine, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Black Rice Bran Extract, Panthenol, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, PEG-60 Hydrogenated Castor Oil, Glyceryl Caprylate, Xanthan Gum, Potassium Hydroxide, Ethylhexylglycerin, Glyceryl Glucoside, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Propolis Extract, Sambucus Nigra Flower Extract, Eucalyptus Globulus Leaf Extract, Pantolactone, Disodium EDTA, Fragrance

  • PURPOSE

    Skin Protectact

  • WARNINGS

    Precautions of Use
    1. If rash, redness, swelling, itching or other adverse reactions occur as a result of exposure to sunlight during or after use, consult a doctor / specialist.
    2. Refrain from using on wound sites.
    3. Storage and handling precautions:
    i) Keep out of reach of children.
    ii) Keep away from direct sunlight
    4. Avoid applying on the eye area
    5. Use immediately after opening the package as the product may become dry, and do not reuse.
    6. Be cautious if you have irritation on adhesive bandages and poultices.

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    1. After washing your face, apply toner to smooth uneven skin.Tear open the pouch at the top and pull out the sheet mask.
    2. Unfold the mask and place it onto your face, aligning the holes with your eyes, nose and mouth.
    3. Remove the sheet mask after relaxing for about 10 - 20 minutes.
    4. Gently massage the leftover essence into your skin.

  • DOSAGE & ADMINISTRATION

    1. After washing your face, apply toner to smooth uneven skin.Tear open the pouch at the top and pull out the sheet mask.
    2. Unfold the mask and place it onto your face, aligning the holes with your eyes, nose and mouth.
    3. Remove the sheet mask after relaxing for about 10 - 20 minutes.
    4. Gently massage the leftover essence into your skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RAYDERM HYDRATING MASK 
    glycerin mask liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72543-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) glycerin3.84 g  in 24 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.12 g  in 24 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    SAMBUCUS CANADENSIS FLOWER (UNII: C87P971T6W)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72543-001-0124 mL in 1 PACKAGE; Type 0: Not a Combination Product10/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/11/2018
    Labeler - VORY MEDICAL. Inc (694721104)
    Registrant - VORY MEDICAL. Inc (694721104)
    Establishment
    NameAddressID/FEIBusiness Operations
    VORY MEDICAL. Inc694721104manufacture(72543-001)