Label: MEDERMA ADVANCED- allantoin gel

  • NDC Code(s): 46783-801-20, 46783-801-50
  • Packager: Merz North America
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated March 11, 2024

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  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Box Label

    NDC 46783-801-50

    MEDERMA
    ADVANCED GEL

    50 mL

    Manufactured by:
    Merz Pharma GmbH & Co. KGaA
    Reinheim, Germany

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Box Label
  • INGREDIENTS AND APPEARANCE
    MEDERMA ADVANCED 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46783-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ONION (UNII: 492225Q21H)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46783-801-201 in 1 BOX11/01/2013
    120 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:46783-801-501 in 1 BOX11/01/2013
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY11/01/2013
    Labeler - Merz North America (028147846)