MEDERMA PM- dimethicone cream

Mederma PM by

Drug Labeling and Warnings

Mederma PM by is a Otc medication manufactured, distributed, or labeled by Merz Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

MEDERMA PM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0259-2202
Route of Administration	TOPICAL

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 (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
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	11/01/2013
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0259-2202-48	1 in 1 BOX	11/01/2013
2		48 g in 1 JAR; Type 0: Not a Combination Product

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)