Label: MEDERMA FOR KIDS- allantoin gel

  • NDC Code(s): 73302-202-20
  • Packager: HRA PHARMA AMERICA, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • Active Ingredients

    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 punctured 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, Ext. Violet 2, Red 4, Sodium Chloride, Sodium Sulfate
  • Questions or Comments?

    •
    For more information call 1-833-426-6733 or visit www.mederma.com
  • PRINCIPAL DISPLAY PANEL

    MEDERMA® for Kids™

    Clinically shown to visibly reduce the appearance of scars

    For Ages 2+

    goes on purple & rubs in clear

    Unique Triple-Action Formula with kid-friendly scent

    No 1 Pediatrician recommended scar brand

    Skin Protectant

    1 x GEL TUBE

    NET WT. 0.7 0z (20g)

    carton
  • INGREDIENTS AND APPEARANCE
    MEDERMA FOR KIDS 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73302-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Polyethylene Glycol 200 (UNII: R95B8J264J)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Alcohol (UNII: 3K9958V90M)  
    Onion (UNII: 492225Q21H)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Sorbic Acid (UNII: X045WJ989B)  
    Ext. D&C Violet No. 2 (UNII: G5UX3K0728)  
    Fd&C Red No. 4 (UNII: X3W0AM1JLX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Sulfate (UNII: 0YPR65R21J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73302-202-201 in 1 CARTON10/01/2020
    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 DrugM01610/01/2020
    Labeler - HRA PHARMA AMERICA, INC. (081160441)
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