Mederma Pm
Dimethicone
Hra Pharma America, Inc.
Human Otc Drug
NDC 73302-203Mederma Pm also known as Dimethicone is a human otc drug labeled by 'Hra Pharma America, Inc.'. National Drug Code (NDC) number for Mederma Pm is 73302-203. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Mederma Pm drug includes Dimethicone - 20 mg/g . The currest status of Mederma Pm drug is Active.
Drug Information:
| Drug NDC: | 73302-203 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Mederma Pm |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dimethicone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hra Pharma America, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMETHICONE - 20 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Oct, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part347 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | HRA Pharma America, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 244642
1442980
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000010282
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 92RU3N3Y1O
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class PE: | Skin Barrier Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Skin Barrier Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 73302-203-28 | 1 TUBE in 1 BOX (73302-203-28) / 28 g in 1 TUBE | 01 Oct, 2020 | N/A | No |
| 73302-203-48 | 1 JAR in 1 BOX (73302-203-48) / 48 g in 1 JAR | 01 Oct, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients purpose dimethicone 2% skin protectant
Product Elements:
Mederma pm dimethicone dimethicone dimethicone water cetostearyl alcohol pentylene glycol alkyl (c12-15) benzoate dicaprylyl carbonate glycerin arachidyl alcohol alcohol aloe vera leaf cyclomethicone 5 docosanol cyclomethicone 6 arachidyl glucoside onion cetearyl glucoside .alpha.-tocopherol acetate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) hydroxyethyl cellulose (2000 mpa.s at 1%) glycine panthenol bovine type i collagen polyethylene glycol 400 polysorbate 60 sorbitan isostearate citric acid monohydrate sodium hydroxide alanine arginine hydrochloride aspartic acid anhydrous dextrose glutamic acid isopropyl alcohol leucine lysine hydrochloride mannitol sodium lactate sorbitol tromethamine valine potassium sorbate sodium benzoate tocopherol prezatide copper acetate histidine monohydrochloride soy protein isoleucine phenylalanine tyrosine carton
Indications and Usage:
Uses ⢠temporarily protects and helps relieve chapped or cracked skin
Warnings:
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.
Do Not Use:
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.
When Using:
When using this product ⢠do not get into eyes
Dosage and Administration:
Directions ⢠apply as needed
Stop Use:
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
Package Label Principal Display Panel:
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 used once nightly: paraben-free mederma ® pm intensive overnight scar cream with cepalin ® botanical extract is clinically shown to improve softness, texture and appearance of scars from: acne surgery burns injury for best results: start to use mederma ® pm as soon as your wound has closed and apply evenly once nightly for: 8 weeks on new scars 3 â 6 months on old scars during sleep our bodies work harder to reverse the damage caused during the day, repairing and regenerating skin cells at a faster rate. mederma ® pm intensive overnight scar cream is formulated to complement this activity with tripeptol⢠, a skin nourishing complex with peptides, collagen and antioxidants to promote healthy looking skin. unique triple-action formula + tripeptol⢠penetrates beneath the surface of the skin to help: collagen production cell renewal lock-in moisture guaranteed results or your money back manufactured for laboratoire hra pharma distributed by: hra pharma america, inc. morristown, nj 07960. made in germany. mederma ® is a registered trademark of hra pharma. aw00278-02 lot no.: exp. date: upc 810000318094
Further Questions:
Questions or comments? ⢠for more information call 1-833-426-6733 or visit www.mederma.com