Label: MEDERMA ADVANCED SCAR- allantoin gel

  • NDC Code(s): 0259-1105-01, 0259-1105-20, 0259-1105-50
  • Packager: Merz Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

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 February 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Use

    Temporatrily protects and helps relieve chapped or cracked skin

  • Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other information

    Store at room temperature

  • Inactive Ingredients

    Water (purified), PEG 200, Alcohol, Xantham Gum, Allium Cepa (Onion) Bulb Extract, Lecithin, Methylparaben, Sorbic Acid, Panthenol, Sodium Hyaluronate, Fragrance

  • Questions or Comments?

    For more information call 1-888-925-8989 or visit www.mederma.com

  • PRINCIPAL DISPLAY PANEL - 20 g Tube Box

    SKIN CARE FOR SCARS™
    MEDERMA®
    ADVANCED
    SCAR
    GEL

    NET WT. 0.70 OZ. (20g)

    MERZ

    PRINCIPAL DISPLAY PANEL - 20 g Tube Box
  • INGREDIENTS AND APPEARANCE
    MEDERMA ADVANCED SCAR 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0259-1105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Polyethylene Glycol 200 (UNII: R95B8J264J)  
    Alcohol (UNII: 3K9958V90M)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Onion (UNII: 492225Q21H)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Sorbic Acid (UNII: X045WJ989B)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0259-1105-201 in 1 BOX11/01/201308/31/2023
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0259-1105-501 in 1 BOX11/01/201305/31/2024
    250 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0259-1105-011 g in 1 PACKET; Type 0: Not a Combination Product11/01/201305/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/01/201305/31/2024
    Labeler - Merz Pharmaceuticals, LLC (126209282)
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