FDA.reportPublic FDA data

Mederma PM

Manufacturer
Merz Pharmaceuticals, LLC
Effective date
2022-02-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:07:50

Label at a glance#

ProductMederma PM
Active ingredientDimethicone
Label structure10 sections

Dosage and administration

Apply as needed.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

For more information call 1-888-925-8989 or visit www.mederma.com

PRINCIPAL DISPLAY PANEL - 48 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 48 g Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0259-2202-282022-02-25C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-482022-02-25C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-282022-01-28C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-482022-01-28C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-282020-02-07C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-482020-02-07C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-282020-01-31C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM
0259-2202-482020-01-31C16284748780-19d75b9d0-366a-f424-e053-dadaa90a57ceMederma ® PM

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0259-2202-28GM - Gram0259-2202637e1135-930e-4ac1-a350-4589f6c1ea9512022-06-06
0259-2202-48GM - Gram0259-220271ebd141-d817-4da9-9b11-6fa225502da112022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1O2
DimethiconeACTIVE MOIETY92RU3N3Y1O2
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L02
AlanineINACTIVE INGREDIENTOF5P57N2ZX2
AlcoholINACTIVE INGREDIENT3K9958V90M2
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X2
Arachidyl alcoholINACTIVE INGREDIENT1QR1QRA9BU2
Arachidyl glucosideINACTIVE INGREDIENT6JVW35JOOJ2
Arginine HydrochlorideINACTIVE INGREDIENTF7LTH1E20Y2
Aspartic AcidINACTIVE INGREDIENT30KYC7MIAI2
Bovine Type I CollagenINACTIVE INGREDIENTFHJ3ATL51C2
Cetearyl GlucosideINACTIVE INGREDIENT09FUA47KNA2
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S2
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP2
CyclomethiconeINACTIVE INGREDIENTNMQ347994Z2
DextroseINACTIVE INGREDIENTIY9XDZ35W22
Dicaprylyl CarbonateINACTIVE INGREDIENT609A3V1SUA2
DocosanolINACTIVE INGREDIENT9G1OE216XY2
Glutamic AcidINACTIVE INGREDIENT3KX376GY7L2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
GlycineINACTIVE INGREDIENTTE7660XO1C2
Histidine MonohydrochlorideINACTIVE INGREDIENT1D5Q932XM62
Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ42
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN162
IsoleucineINACTIVE INGREDIENT04Y7590D772
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163022
LeucineINACTIVE INGREDIENTGMW67QNF9C2
Lysine HydrochlorideINACTIVE INGREDIENTJNJ23Q2COM2
MannitolINACTIVE INGREDIENT3OWL53L36A2
OnionINACTIVE INGREDIENT492225Q21H2
PanthenolINACTIVE INGREDIENTWV9CM0O67Z2
Pentylene GlycolINACTIVE INGREDIENT50C1307PZG2
PhenylalanineINACTIVE INGREDIENT47E5O17Y3R2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ42
Prezatide CopperINACTIVE INGREDIENT6BJQ43T1I92
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I2
Sodium LactateINACTIVE INGREDIENTTU7HW0W0QT2
SorbitolINACTIVE INGREDIENT506T60A25R2
Soy ProteinINACTIVE INGREDIENTR44IWB3RN52
TromethamineINACTIVE INGREDIENT023C2WHX2V2
TyrosineINACTIVE INGREDIENT42HK56048U2
ValineINACTIVE INGREDIENTHG18B9YRS72
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0259-22020259-2202-28, 0259-2202-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
water059QF0KO0RIACT
Onion492225Q21HIACT
Cetostearyl Alcohol2DMT128M1SIACT
GlycerinPDC6A3C0OXIACT
Dicaprylyl Carbonate609A3V1SUAIACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Pentylene Glycol50C1307PZGIACT
CyclomethiconeNMQ347994ZIACT
Arachidyl alcohol1QR1QRA9BUIACT
Alcohol3K9958V90MIACT
Docosanol9G1OE216XYIACT
Arachidyl glucoside6JVW35JOOJIACT
Cetearyl Glucoside09FUA47KNAIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)S38J6RZN16IACT
Sodium Hydroxide55X04QC32IIACT
Aloe Vera LeafZY81Z83H0XIACT
GlycineTE7660XO1CIACT
PanthenolWV9CM0O67ZIACT
Bovine Type I CollagenFHJ3ATL51CIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium BenzoateOJ245FE5EUIACT
Citric Acid Monohydrate2968PHW8QPIACT
Arginine HydrochlorideF7LTH1E20YIACT
LeucineGMW67QNF9CIACT
Lysine HydrochlorideJNJ23Q2COMIACT
AlanineOF5P57N2ZXIACT
Sodium LactateTU7HW0W0QTIACT
Aspartic Acid30KYC7MIAIIACT
Dextrose, unspecified formIY9XDZ35W2IACT
Glutamic Acid3KX376GY7LIACT
Isopropyl AlcoholND2M416302IACT
Mannitol3OWL53L36AIACT
Sorbitol506T60A25RIACT
Tromethamine023C2WHX2VIACT
ValineHG18B9YRS7IACT
Prezatide Copper6BJQ43T1I9IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 13 · 726 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
TromethamineTROMETHAMINE023C2WHX2VGEL / TRANSDERMAL10 mgExact identifier — unii candidate
28 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
MannitolMANNITOL3OWL53L36APOWDER / ORAL4352 mgExact identifier — unii candidate
65 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium LactateSODIUM LACTATETU7HW0W0QTINJECTION, SOLUTION / INFILTRATION0.17 %v/vExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
TromethamineTROMETHAMINE023C2WHX2VSOLUTION/ DROPS / OPHTHALMIC0.8 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
ValineVALINEHG18B9YRS7INJECTION / INTRAVENOUS0.84 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
TromethamineTROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRAVENOUS300 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / OPHTHALMIC46 mgExact identifier — unii candidate
36 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION/ DROPS / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
ValineVALINEHG18B9YRS7INJECTION, SOLUTION / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycineGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
36 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii candidate
65 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii candidate
65 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
DextroseDEXTROSEIY9XDZ35W2TABLET, COATED / ORAL132 mgExact identifier — unii candidate
21 equally ranked IID candidates
TromethamineTROMETHAMINE023C2WHX2VINJECTION / INTRAVENOUS1134 mgExact identifier — unii candidate
28 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
TromethamineTROMETHAMINE023C2WHX2VINJECTION / INTRA-ARTERIAL562 mgExact identifier — unii candidate
28 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
15 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2988a54d-5ee7-47bd-a00a-6e43993c5894e1864a26-e8a3-4c9d-a468-ea020fdc30e12022-02-23WarningsExact identifier
spl id: 2988a54d-5ee7-47bd-a00a-6e43993c5894
spl set id: e1864a26-e8a3-4c9d-a468-ea020fdc30e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.