Mederma® for Kids™

Mederma® for Kids™

Drug Labeling and Warnings

Drug Details

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MEDERMA FOR KIDS- allantoin gel 
Merz Pharmaceuticals, LLC

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.

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Mederma® for Kids

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
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 CARTON05/01/201402/15/2020
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 FINALpart34705/01/201402/15/2020
Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2020
 
Merz Pharmaceuticals, LLC


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