{"clinical_pharmacology":["CLINICAL PHARMACOLOGY 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. PHARMACOKINETICS The mechanism of action of topical urea is not yet known."],"contraindications":["CONTRAINDICATIONS HYDRO 35 Foam should not be used by persons who have a known hypersensitivity to urea or any of the listed ingredients."],"description":["DESCRIPTION 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: Chemical Structure"],"description_table":["
CHEMICAL STRUCTURE
Urea has the following chemical structure:
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 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. image"],"dosage_and_administration_table":["
Shake canister vigorously before each use. Tum upside down (nozzle down) to dispense. Depress ridged portion of dispenser, as illustrated at right.
"],"effective_time":"20160715","how_supplied":["HOW SUPPLIED 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)."],"id":"a2ebc605-02a0-4ce1-b4c1-0d752094ad07","indications_and_usage":["INDICATIONS FOR USE 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."],"nursing_mothers":["Nursing Mothers 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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 150 g Canister Label NDC 23710-035-15 HYDRO 35 ® 35% UREA IN A VEHICLE CONTAINING LACTIC ACID HYDRATING TOPICAL FOAM PRODERM TECHNOLOGY ® Rx Only NET WT. 5.3 OZ (150 g) PRINCIPAL DISPLAY PANEL - 150 g Canister Label","PRINCIPAL DISPLAY PANEL - 150 g Canister Carton NDC 23710-035-15 HYDRO 35 ® 35% UREA IN A VEHICLE CONTAINING LACTIC ACID HYDRATING TOPICAL FOAM PRODERM TECHNOLOGY ® Rx Only NET WT. 5.3 OZ (150 g) PRINCIPAL DISPLAY PANEL - 150 g Canister Carton"],"pharmacokinetics":["PHARMACOKINETICS The mechanism of action of topical urea is not yet known."],"precautions":["PRECAUTIONS 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. Pregnancy (Category C) 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. Nursing Mothers 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."],"pregnancy":["Pregnancy (Category C) 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."],"set_id":"c1fc0ed7-6383-455a-98c3-ef44b312fc0d","spl_product_data_elements":["Hydro 35 Urea in a water and lipid based foam containing lactic acid UREA UREA DIMETHICONE ETHYLPARABEN GLYCERIN LACTIC ACID, UNSPECIFIED FORM METHYLPARABEN PHENOXYETHANOL POLYSORBATE 20 POVIDONES PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID TROLAMINE BUTANE PROPANE"],"spl_unclassified_section":["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.","INGREDIENTS 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.","US Patent 5,993.830 Manufactured in the USA for Exeltis USA Dermatology, LLC Florham Park, NJ 07932 www.exeltisUSA.com © 2012 Exeltis USA Dermatology, LLC Rev 09/2015 51000020"],"storage_and_handling":["Store at controlled room temperature 15° to 25°c (59° to 77°F)."],"version":"2","warnings":["WARNINGS 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."]}