Label: MEDERMA FOR KIDS- allantoin gel

  • NDC Code(s): 0259-1101-20
  • Packager: Merz Pharmaceuticals, LLC
  • 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 February 22, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Allantoin 1%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily 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, PEG-4, Xanthan Gum, Alcohol, Allium Cepa (Onion) Bulb Extract, Fragrance, Methylparaben, Sorbic Acid, D&C Violet No. 2, FD&C Red No. 4.

  • Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL - 20 g Tube Carton

    SKIN CARE FOR SCARS™
    MEDERMA®
    for Kids

    FROM THE LEADER IN SCAR MANAGEMENT

    NET WT. 0.70 OZ. (20g)

    Principal Display Panel - 20 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MEDERMA FOR KIDS 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0259-1101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    ONION (UNII: 492225Q21H)  
    ALCOHOL (UNII: 3K9958V90M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBIC ACID (UNII: X045WJ989B)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0259-1101-201 in 1 CARTON05/01/201408/31/2023
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/01/201408/31/2023
    Labeler - Merz Pharmaceuticals, LLC (126209282)