NDC 53633-100 Marly Skin Guard

Dimethicone

NDC Product Code 53633-100

NDC CODE: 53633-100

Proprietary Name: Marly Skin Guard What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dimethicone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 53633 - Marly Skin Na Inc

NDC 53633-100-01

Package Description: 100 mL in 1 CAN

NDC Product Information

Marly Skin Guard with NDC 53633-100 is a a human over the counter drug product labeled by Marly Skin Na Inc. The generic name of Marly Skin Guard is dimethicone. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Marly Skin Na Inc

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Marly Skin Guard Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIMETHICONE 1 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PROPANE (UNII: T75W9911L6)
  • BUTANE (UNII: 6LV4FOR43R)
  • TROLAMINE STEARATE (UNII: 1J6JM3JE61)
  • SORBITOL (UNII: 506T60A25R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Marly Skin Na Inc
Labeler Code: 53633
FDA Application Number: part356 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-08-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Marly Skin Guard Product Label Images

Marly Skin Guard Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredients Dimethicone 1%

Otc - Purpose

Purpose Skin Protectant

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

UsesTemporarily protects and helps relieve chapped or cracked skinHelps protect from the drying effects of wind and cold weather

Warnings

WarningsAvoid spraying in eyesContents under pressure. Flammable. Do not puncture or incinerate. Do not store at temperatures above 120 F. Keep out of reach of childrenUse only as directedFor external use onlyDo not use Do not use on puncture wounds, animal bites, serious burnsStop Use and ask a doctor ifCondition worsensSymptoms last more than 7 days or clear up and occur again within a few daysKeep out of reach of children

Dosage & Administration

DirectionsSkin must be clean and dry. Shake well before use. Dispense the foam by pressing the application nozzle while holding can upside down. When applying to hands, a walnut size amount is enough. Good for the entire body. Gently rub the foam into the skin covering all areas for full effect. Allow 3 minutes to dry.

Other Safety Information

Other informationDistributed by Marly Skin USA LLC, 1209 Orange St. Wilmington, DE 19801Made in GermanyMarly Skin Guard forms a two-dimensional skin barrier which helps protectthe skin against allergens, chemicals and toxins. Like an invisible glove. Helps prevent skin problems from incontinence, when wearing gloves and from frequent cleansing and sanitizing. Nongreasy. Skin breathes and perspires normally. Nontoxic and hypoallergenic. for terms and conditions visit: www.marlyskinguard.com

Inactive Ingredient

Inactive IngredientsWater, Propane, Butane, TEA-Stearate, Sorbitol, Propylene Glycol, Glycerin, Methylparaben, Propylparaben, Aloe Barbadensis, tocopherol

* Please review the disclaimer below.