Mederma® PM

Mederma® PM

Drug Labeling and Warnings

Drug Details

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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

  • 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, 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 - 48 g Jar Carton

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

Formulated to work with your skin's
nighttime regenerative activity

Net Wt. 1.7 oz. (48g)

PRINCIPAL DISPLAY PANEL - 48 g Jar Carton
MEDERMA PM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0259-2202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 (100000 MPA.S AT 1.5%) (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, unspecified form (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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0259-2202-281 in 1 BOX11/01/201302/15/2020
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 0259-2202-481 in 1 BOX11/01/201302/15/2020
248 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/201302/15/2020
Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2020
 
Merz Pharmaceuticals, LLC


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