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NDC 00259-2202-28 Mederma PM 20 mg/g Details

Mederma PM 20 mg/g

Mederma PM is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Merz Pharmaceuticals, LLC. The primary component is DIMETHICONE.

Product Information

NDC	00259-2202
Product ID	0259-2202_2988a54d-5ee7-47bd-a00a-6e43993c5894
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mederma PM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/g
Substance Name	DIMETHICONE
Labeler Name	Merz Pharmaceuticals, LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 00259-2202-28 (00259220228)

Pricing Information	N/A
NDC Package Code	0259-2202-28
Billing NDC	00259220228
Package	1 TUBE in 1 BOX (0259-2202-28) / 28 g in 1 TUBE
Marketing Start Date	2013-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e1864a26-e8a3-4c9d-a468-ea020fdc30e1 Details

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)

PRINCIPAL DISPLAY PANEL - 48 g Jar Carton

INGREDIENTS AND APPEARANCE

MEDERMA PM

dimethicone cream

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0259-2202-28	1 in 1 BOX	11/01/2013	07/31/2024
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0259-2202-48	1 in 1 BOX	11/01/2013	04/30/2023
2		48 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	11/01/2013	07/31/2024

Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2022

Document Id: 2988a54d-5ee7-47bd-a00a-6e43993c5894

Set id: e1864a26-e8a3-4c9d-a468-ea020fdc30e1

Version: 6

Effective Time: 20220223