Label: RAYDERM RE-GENERATING CREAM- glycerin cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 11, 2018

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  • ACTIVE INGREDIENT

    Glycerin (25.003%) - Skin Protectact

  • INACTIVE INGREDIENT

    Purified Water, Propanediol, Pentylene Glycol, Caprylic/Capric Triglyceride, Rosehip Fruit Oil, Niacinamide, Black Rice Bran Extract, Butylene Glycol, rh-Polypeptide-1, rh-Oligopeptide-1, rh-Oligopeptide-2, rh-Polypeptide-62, rh-Polypeptide-3, Ceramide NP, Panthenol, Tocopheryl Acetate, Nelumbium Speciosum Flower Extract, Hydrolyzed Hyaluronic Acid, Pseudoalteromonas Fermented Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydrogenated Lecithin, Adenosine, Sodium Hyaluronate, Caprylyl Glycol, 1,2-Hexanediol

  • 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

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Apply the cream on the skin and spread evenly.

  • DOSAGE & ADMINISTRATION

    Apply the cream on the skin and spread evenly.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RAYDERM RE-GENERATING CREAM 
    glycerin cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72543-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) glycerin12.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CERAMIDE NP (UNII: 4370DF050B)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    ADENOSINE (UNII: K72T3FS567)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72543-002-0150 mL in 1 PACKAGE; Type 0: Not a Combination Product10/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/11/2018
    Labeler - VORY MEDICAL. Inc (694721104)
    Registrant - VORY MEDICAL. Inc (694721104)
    Establishment
    NameAddressID/FEIBusiness Operations
    VORY MEDICAL. Inc694721104manufacture(72543-002)
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