Advertisement

Topics

HYDRO 35® Hydrating Topical Foam | Hydro 35 [Exeltis USA Dermatology, LLC] | BioPortfolio

12:47 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

For Topical Dermatological Use Only

Rx Only - Caution: Federal Law restricts this product to sale by, or on the order of a licensed healthcare practitioner.

HYDRO 35 Foam is a keratolytic agent delivered in a water & lipid based emollient foam containing lactic acid. This foam gently softens excess tissue to enhance removal from skin and nails, while rehydrating healthy tissue. Each gram contains 35% Urea as the active ingredient.

CHEMICAL STRUCTURE
Urea has the following chemical structure:

Topically applied urea dissolves the intercellular matrix of the skin which results in softening of the hyperkeratotic tissue, and thus enhances shedding of scaly, dry skin. Urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.

The mechanism of action of topical urea is not yet known.

For enzyme debridernent and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection. Necrotic tissue. fibrinous or purulent debris. Or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis. psoriasis, xerosis.ichthyosis, eczema.keratosis.keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.

HYDRO 35 Foam should not be used by persons who have a known hypersensitivity to urea or any of the listed ingredients.

For external use only. Not for ophthalmic, oral, and or intravaginal use. Avoid contact with the eyes, lips, and other mucous membranes.

KEEP THIS AND OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.

Contains flammable materials. Contents under pressure. Do not puncture or incinerate. Do not expose to temperatures over 120'F (48'C) even when empty.

Use only as directed by a healthcare practitioner. Do not use to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and contact prescribing healthcare practitioner.

Animal reproduction studies have not been conducted with Hydro 35 Foam. It is also not known whether Hydro 35 Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydro 35 Foam should be given to a pregnant woman only if clearly needed.

It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering HYDRO 35 Foam to nursing mothers.

Apply to affected area twice a day unless otherwise directed by a prescribing healthcare practitioner. HYDRO 35 Foam should be rubbed gently into the skin until it is completely absorbed.

Follow these important directions to ensure proper foaming and maximum delivery of product:

Shake canister vigorously before each use. Tum upside down (nozzle down) to dispense. Depress ridged portion of dispenser, as illustrated at right.

Urea 35%, dimethicone, ethylparaben. Glycerin, Lactic acid, methyl paraben, phenoxyethanol, polysorbate 20.povidone, propylene glycol. propylparaben, purified water, Stearic acid, trolamine, and as propellants isobutane and propane.

HYDRO 35 Foam is supplied in a 5.3 ounce (150g) pressurized canister bearing the NDC Number 23710-035-15 and i n a 0.79 ounce (22g) pressurized canister bearing the NDC Number 23710-035-20.

Store at controlled room temperature 15° to 25°c (59° to 77°F).

US Patent 5,993.830

Manufactured in the USA forExeltis USA Dermatology, LLCFlorham Park, NJ 07932

www.exeltisUSA.com © 2012 Exeltis USA Dermatology, LLC

Rev 09/201551000020

NDC 23710-035-15

HYDRO 35 35% UREA IN A VEHICLECONTAINING LACTIC ACID

HYDRATING TOPICAL FOAM

PRODERM TECHNOLOGY

Rx OnlyNET WT. 5.3 OZ (150 g)

NDC 23710-035-15

HYDRO 35 35% UREA IN A VEHICLECONTAINING LACTIC ACID

HYDRATING TOPICAL FOAMPRODERM TECHNOLOGY

Rx OnlyNET WT. 5.3 OZ (150 g)

Manufacturer

Exeltis USA Dermatology, LLC

Active Ingredients

Source

Clinical Trials [40 Associated Clinical Trials listed on BioPortfolio]

An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis

Efficacy of Hydrotherapy in Peripheral Neuropathy

The purpose of the study is to evaluate the efficacy of hydrotherapy on pain and balance in patients affected by neuropathy.

Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors

Breast cancer survivors often suffer from climacteric symptoms caused by treatment or diagnosis of their disease. Hormone replacement therapy is contraindicated and other pharmacological ...

Hydrotherapy Versus Physiotherapy for Short-Term Rehabilitation After Primary TKR

Primary objective: To compare the effects of short term therapy post total knee replacement (TKR) between a hydrotherapy treatment group and a physiotherapy treatment group. Second...

EVENT: Hydrotherapy and Deep Venous Thrombosis

The main objective of this study is to demonstrate that hydrotherapy in a specific place can reduce the risk of post-thrombotic syndrome.

PubMed Articles [68 Associated PubMed Articles listed on BioPortfolio]

Simultaneous removal of aniline, antimony and chromium by ZVI coupled with HO: Implication for textile wastewater treatment.

Aniline, antimony (Sb) and chromium (Cr) are typical and regulated co-contaminants in textile wastewater, but their removal was often investigated individually. In this work, simultaneous removal of a...

Anti-proliferative activity and cell metabolism of hydroxycinnamic acids in human colon adenocarcinoma cell lines.

In this study, we investigated the anti-proliferative activity and the stability and metabolic fate of the main dietary hydroxycinnamates, using two colonic adenocarcinoma cell models (Caco-2 and SW48...

Improved GAFF2 parameters for fluorinated alkanes and mixed hydro- and fluorocarbons.

We present improved molecular mechanics models for perfluorocarbons and mixed hydro- and fluorocarbons, based on the GAFF2 force field. Benchmarking was performed for a series of single molecule geome...

Policy choice and riverine water quality in developing countries: An integrated hydro-economic modelling approach.

Industrialization and urbanization, as a result of rapid economic development, have led to the deterioration of water quality in many rivers in developing countries. The Kelani River in Sri Lanka prov...

Embolism resistance drives the distribution of Amazonian rainforest tree species along hydro-topographic gradients.

Species distribution is strongly driven by local and global gradients in water availability but the underlying mechanisms are not clear. Vulnerability to xylem embolism (P ) is a key trait that indica...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

BioPortfolio - life science, medical devices and pharmaceutical conference
BioPortfolio is a leading news, information and knowledge resource covering the global life science industries impacted on by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to so...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record