MEDERMA PM- dimethicone cream

Mederma PM by

Drug Labeling and Warnings

Mederma PM by is a Otc medication manufactured, distributed, or labeled by HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dimethicone 2%

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 punctured 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, Pentylene Glycol, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Glycerin, Arachidyl Alcohol, Alcohol, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Behenyl Alcohol, Cyclohexasiloxane, Arachidyl Glucoside, Allium Cepa (Onion) Bulb Extract, Fragrance, Cetearyl Glucoside, Tocopheryl Acetate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Glycine, Panthenol, Hydrolyzed Collagen, PEG-400, Polysorbate 60, Sorbitan Isostearate, Citric Acid, Sodium Hydroxide, Alanine, Arginine HCl, Aspartic acid, Glucose, Glutamic acid, Isopropyl alcohol, Leucine, Lysine HCl, Mannitol, Sodium Lactate, Sorbitol, Tromethamine, Valine, Potassium sorbate, Sodium benzoate, Tocopherol, Bis(Tripeptide-1) Copper Acetate, Histidine HCl, Hydrolyzed Soy Protein, Isoleucine, Phenylalanine, Tyrosine

Questions or Comments

• For more information call 1-833-426-6733 or visit www.mederma.com

PRINCIPAL DISPLAY PANEL

MEDERMA® PM

Intensive Overnight Scar Cream

Specially formulated to work with your skin's nighttime regenerative activity to visibly reduce appearance of scars while you sleep

No 1 Dermatologist recommended scar brand

Skin Protectant

1x CREAM TUBE

NET WT. 1.0 Oz (28g)

Unique Triple - Action Formula + TriPeptol™ penetrates into the skin

INGREDIENTS AND APPEARANCE

MEDERMA PM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73302-203
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)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Pentylene Glycol (UNII: 50C1307PZG)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Glycerin (UNII: PDC6A3C0OX)
Arachidyl alcohol (UNII: 1QR1QRA9BU)
Alcohol (UNII: 3K9958V90M)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Docosanol (UNII: 9G1OE216XY)
Cyclomethicone 6 (UNII: XHK3U310BA)
Arachidyl glucoside (UNII: 6JVW35JOOJ)
Onion (UNII: 492225Q21H)
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)
Glycine (UNII: TE7660XO1C)
Panthenol (UNII: WV9CM0O67Z)
Bovine Type I Collagen (UNII: FHJ3ATL51C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Polysorbate 60 (UNII: CAL22UVI4M)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Hydroxide (UNII: 55X04QC32I)
Alanine (UNII: OF5P57N2ZX)
Arginine Hydrochloride (UNII: F7LTH1E20Y)
Aspartic Acid (UNII: 30KYC7MIAI)
Anhydrous Dextrose (UNII: 5SL0G7R0OK)
Glutamic Acid (UNII: 3KX376GY7L)
Isopropyl Alcohol (UNII: ND2M416302)
Leucine (UNII: GMW67QNF9C)
Lysine Hydrochloride (UNII: JNJ23Q2COM)
Mannitol (UNII: 3OWL53L36A)
Sodium Lactate (UNII: TU7HW0W0QT)
Sorbitol (UNII: 506T60A25R)
Tromethamine (UNII: 023C2WHX2V)
Valine (UNII: HG18B9YRS7)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
Tocopherol (UNII: R0ZB2556P8)
Prezatide Copper Acetate (UNII: A3LEI4P1NB)
Histidine Monohydrochloride (UNII: 1D5Q932XM6)
Soy Protein (UNII: R44IWB3RN5)
Isoleucine (UNII: 04Y7590D77)
Phenylalanine (UNII: 47E5O17Y3R)
Tyrosine (UNII: 42HK56048U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73302-203-28	1 in 1 BOX	10/01/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73302-203-48	1 in 1 BOX	10/01/2020
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 Drug	M016	10/01/2020

Labeler - HRA PHARMA AMERICA, INC. (081160441)