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 Type HUMAN OTC DRUG Item Code (Source) NDC:0259-2202
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
Onion (UNII: 492225Q21H)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Glycerin (UNII: PDC6A3C0OX)  
Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Pentylene Glycol (UNII: 50C1307PZG)  
Cyclomethicone (UNII: NMQ347994Z)  
Arachidyl alcohol (UNII: 1QR1QRA9BU)  
Alcohol (UNII: 3K9958V90M)  
Docosanol (UNII: 9G1OE216XY)  
Arachidyl glucoside (UNII: 6JVW35JOOJ)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
Hydroxyethyl Cellulose (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Glycine (UNII: TE7660XO1C)  
Panthenol (UNII: WV9CM0O67Z)  
Bovine Type I Collagen (UNII: FHJ3ATL51C)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Arginine Hydrochloride (UNII: F7LTH1E20Y)  
Leucine (UNII: GMW67QNF9C)  
Lysine Hydrochloride (UNII: JNJ23Q2COM)  
Alanine (UNII: OF5P57N2ZX)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Aspartic Acid (UNII: 30KYC7MIAI)  
Dextrose (UNII: IY9XDZ35W2)  
Glutamic Acid (UNII: 3KX376GY7L)  
Isopropyl Alcohol (UNII: ND2M416302)  
Mannitol (UNII: 3OWL53L36A)  
Sorbitol (UNII: 506T60A25R)  
Tromethamine (UNII: 023C2WHX2V)  
Valine (UNII: HG18B9YRS7)  
Prezatide Copper (UNII: 6BJQ43T1I9)  
Soy Protein (UNII: R44IWB3RN5)  
Histidine Monohydrochloride (UNII: 1D5Q932XM6)  
Isoleucine (UNII: 04Y7590D77)  
Phenylalanine (UNII: 47E5O17Y3R)  
Tyrosine (UNII: 42HK56048U)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0259-2202-28 1 in 1 BOX
1 28 g in 1 TUBE
2 NDC:0259-2202-48 1 in 1 BOX
2 48 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 11/01/2013
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