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
  • 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 27, 2020

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTSPURPOSE
    Allantoin 1%Skin Protectant
  • INDICATIONS & USAGE

    USES • Temporarily protects and helps relieve chapped or cracked skin

  • WARNINGS

    WARNINGS • For external use only

  • WHEN USING

    When using this product  • Do not get into eyes

  • ASK DOCTOR

    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

    Do not use on • Deep or punctured wounds • Animal bites • Serious burns

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS • Apply as needed

  • STORAGE AND HANDLING

    OTHER INFORMATION • Store at room temperature

  • INACTIVE INGREDIENT

    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

    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+

    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)

    Effective treatment, with Cepalin® botanical extract for old and new scars caused by:

    • Cuts & Scrapes
    • Stitches
    • Burns
    • Surgery

    Unique Triple-Action Formula penetrates beneath the surface of the skin to help:

    • Collagen production
    • Cell renewal
    • Lock-in moisture

    For best results: Start to use Mederma® for Kids™ as soon as their wound has closed and apply evenly at least 3 times a day for:

    • 8 weeks on new scars
    • 3 - 6 months on older scars

    *No. 1 recommended brand of scar reduction treatments

    Mederma® for Kids™ is for use on children 2-12 years of age. Ask your doctor before use on children under the age of 2.

    Guaranteed results or your money back

    Manufactured for Laboratoire HRA Pharma
    Distributed by: HRA Pharma America, Inc.
    Morristown, NJ 07960.
    Made in Germany.
    Mederma® is a registered trademark of HRA Pharma.

    Lot  

    Exp. Date 

    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 finalpart34710/01/2020
    Labeler - HRA Pharma America, Inc. (081160441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merz Pharma GmbH & Co KGaA342543179manufacture(73302-202)
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