MEDERMA PM- dimethicone cream 
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® PM

Drug Facts

Active Ingredients

Dimethicone 2%

Purpose

Skin Protectant

Use

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

Other Information

Store at room temperature.

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Pentylene Glycol, Cyclomethicone, Arachidyl Alcohol, Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Allium Cepae (Onion) Bulb Extract, Copper Tripeptide-1, Aloe Barbadensis Leaf, Cetearyl Glucoside, Tocopherol Acetate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Hydrolyzed Soy Protein, Glycine, Panthenol, Hydrolyzed Collagen, PEG-400, Arginine HCL, Leucine, Lysine Hydrochloride, Alanine, Sodium Lactate, Aspartic Acid, Glucose, Glutamic Acid, Isopropyl Alcohol, Mannitol, Sorbitol, Tromethamine, Valine, Histidine Hydrochloride, Isoleucine, Phenylalanine, Tyrosine, Potassium Sorbate, Sodium Benzoate, Citric Acid, Sodium Hydroxide, Fragrance.

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 28g Tube Box

SKIN CARE FOR SCARS™
MEDERMA® PM
INTENSIVE OVERNIGHT SCAR CREAM

Formulated to work with
your skin's nighttime
regenerative activity

NEW

Net Wt. 1.0 oz. (28g)

Principal Display Panel - 28g Tube Box
MEDERMA PM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0259-2202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
Onion 
Cetostearyl Alcohol 
Glycerin 
Dicaprylyl Carbonate 
Alkyl (C12-15) Benzoate 
Pentylene Glycol 
Cyclomethicone 
Arachidyl alcohol 
Alcohol 
Docosanol 
Arachidyl glucoside 
Cetearyl Glucoside 
.Alpha.-Tocopherol Acetate 
Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) 
Hydroxyethyl Cellulose (2000 MPA.S AT 1%) 
Sodium Hydroxide 
Aloe Vera Leaf 
Glycine 
Panthenol 
Bovine Type I Collagen 
POLYETHYLENE GLYCOL 400 
Potassium Sorbate 
Sodium Benzoate 
Citric Acid Monohydrate 
Arginine Hydrochloride 
Leucine 
Lysine Hydrochloride 
Alanine 
Sodium Lactate 
Aspartic Acid 
Dextrose 
Glutamic Acid 
Isopropyl Alcohol 
Mannitol 
Sorbitol 
Tromethamine 
Valine 
Prezatide Copper 
Soy Protein 
Histidine Monohydrochloride 
Isoleucine 
Phenylalanine 
Tyrosine 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0259-2202-281 in 1 BOX
128 g in 1 TUBE
2NDC:0259-2202-481 in 1 BOX
248 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2013
Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 11/2013
Document Id: 7bba7bce-e4c1-41ef-aa0b-b0eb4411abd2
Set id: e1864a26-e8a3-4c9d-a468-ea020fdc30e1
Version: 1
Effective Time: 20131108
 
Merz Pharmaceuticals, LLC