MOISTUREWORX- petrolatum spray
MoistureWorx by
Drug Labeling and Warnings
MoistureWorx by is a Otc medication manufactured, distributed, or labeled by DermWorx Incorporated, IGI Laboratories, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient
- Inactive Ingredients
- Use:
- Directions:
- Warnings: For external use only.
- Do not use on:
- Keep out of reach of children.
- Ask a doctor or pharmacist before use
- Stop use
- Patient Information
- Active Ingredient:
- Inactive Ingredients:
- Use:
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Clinical Pharmacology:
The outer layer of skin consists of dead skin cells which protect the delicate living cells of the deeper layers beneath. This outer layer needs to stay moisturized in order to protect the deeper layers of skin. To keep the moisture (water) from leaving the outer layer, your skin produces natural oils. These oils also help keep irritants from the deeper layers of skin.
Regular washing with soap, or exposure to chemicals, can remove these natural oils. When the natural oil is stripped from the outer layer, moisture quickly leaves the surface resulting in dry, irritated, and itchy skin. Worse, the deeper layers of skin are now left exposed to harsh damaging irritants such as detergents, powder, etc. This results in more dry, irritated, and itchy skin that ultimately becomes chapped, cracked and damaged.
Everyday skin lotions only attempt to replace natural oils with artificial ones. This is a temporary relief but does little to heal the skin. Regular use of these lotions can actually cause the skin to produce less natural oils. Instead of attempting to replace these natural oils, MoistureWorx™, when applied to the skin, forms a moisture-barrier with the outer layer of dead skin cells. Thus, MoistureWorx™ helps reduce the natural oil and moisture loss, allowing the skin to heal itself. MoistureWorx™ helps the outer layer of skin keep its natural oils and moisturizers that protect the deeper layers of skin, leaving skin soft and supple. MoistureWorx™ keeps the outer layer of skin functioning so it can breathe and perspire naturally.
The active ingredient in MoistureWorx™ is white petrolatum, one of the most common dermal barrier ingredients. Most white petrolatum-based products currently marketed by cosmetic and pharmaceutical companies are in a cream, lotion or ointment form. However, these products are thick, oily and aesthetically unpleasant. The occlusive nature and moisturizing properties are desirable, but the heavy, characteristic feel of white petrolatum is not.
The use of white petrolatum as an emollient has been well accepted for dry skin conditions, especially with flaking skin such as sunburn and chapping. It has been shown that when white petrolatum is applied to sunburned skin, evaporation is curtailed - it acts as a barrier to loss of moisture from the epidermis.
White petrolatum has a long history of consumer use, efficacy and safety. As a result, significant evidence of efficacy and safety exists from the universal use of white petrolatum over many decades for a wide variety of topical indications. Studies have shown that when large amounts of white petrolatum are ingested, the product is essentially nontoxic. It has even been approved as a direct food additive. Further, it has been established that white petrolatum is not absorbed through intact or injured skin and is neither sensitizing nor irritating.
As a result, clinical and marketing experience has confirmed that white petrolatum is safe when used as a skin protectorant. It has an extremely low risk in actual consumer use situations. Moreover, petroleum provides a favorable public health benefit, requires no specific dosage limitation, and requires few specific warnings and no general warnings (e.g. pregnancy or overdose).
The ease of application and delivery of white petrolatum over a relatively large surface area was a key consideration in developing MoistureWorx™. DermWorx has incorporated a novel microencapsulation technique (Novasome®) in the formulation that will significantly increase the aqueous solubility of white petrolatum. This technology utilizes proprietary organized lipid structures and lipid vesicle encapsulation technologies and provides for a nanoparticle in an aqueous transport system. Using this technology, high concentrations of thick solids such as white petrolatum can be transformed into water-based sprayable products.
To evaluate the moisturization efficacy of MoistureWorx™, a clinical study was performed in thirty-three (33) subjects ranging in age from 21 to 60 years with mild to moderate dry skin. MoistureWorx™ was applied two different ways, as a “leave-on” and as a “wipe-off” product.
Moisturization efficacy was determined via a measurement of the skin moisture content (DPM).
Trans-epidermal water loss (TEWL) was also determined.
The results show that MoistureWorx™ used either as a “leave-on” or as a “wipe-off” product, was effective in moisturizing the skin. In addition, the rate of moisture loss through the skin was significantly reduced.
The barrier durability of MoistureWorx™ in protecting the skin from irritation resulting from exposure to know irritants was also evaluated. Twenty-nine (29) subjects completed the study. Sodium lauryl sulfate at concentrations of 7.5%, 10.0% and 12.5% and sodium hydroxide at a concentration of 0.75N were applied to a small patch (8 mm in diameter) and the patches were applied to sites, treated and untreated, on each subjects back. The patches were removed at 2, 4 and 8 hours after application and the sites evaluated for dermal irritation due to the irritants.
The results show that MoistureWorx™ protected the skin exposed to the irritants after eight hours vs. unprotected skin.
- Warnings:
- When using this product:
- Do not use on:
- Directions:
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How Supplied:
4 fl. oz spray bottle
NDC: 28109-020-01
Distributed by:
DermWorx, Inc.
Hollywood, FL 33022
E-mail: info@dermworx.com
www.dermworx.com -
Principal Display Panel - Bottle Label
NDC: 28109-020-01
MoistureWorx™
SKIN PROTECTION SPRAY
30% White Petrolatum, USP
Clinically proven and patented formulation, utilizing nanotechnology, that moisturizes and protects the skin
Hypoallergenic Noncomedogenic Fragrance Free
Gently cleanses and moisturizes skin while delivering targeted, encapsulated white petrolatum into the skin's crack and fissures
4 fl. oz. (120 mL)
Bottle Label
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Principal Display Panel - Outer Carton Label
MoistureWorx™
SKIN PROTECTION SPRAY
30% White Petrolatum, USP
Clinically proven and patented formulation, utilizing nanotechnology, that moisturizes and protects the skin
Hypoallergenic Noncomedogenic Fragrance Free
28109-020-06
MoistureWorx™
SKIN PROTECTION SPRAY
30% White Petrolatum, USP
Unit Contains 6 4fl oz (120mL) Bottles
Distributed by DermWorx, Inc. Hollywood, FL 33022
Outer Carton Label
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INGREDIENTS AND APPEARANCE
MOISTUREWORX
petrolatum sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 28109-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 36 mL in 120 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 28109-020-06 6 in 1 CARTON 1 NDC: 28109-020-01 1 in 1 CARTON 1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/27/2008 Labeler - DermWorx Incorporated (015678067) Establishment Name Address ID/FEI Business Operations IGI Laboratories, Inc. 011036910 MANUFACTURE
Trademark Results [MoistureWorx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOISTUREWORX 77410692 3562357 Dead/Cancelled |
JUVENTIO, LLC 2008-03-02 |
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