United States - English - NLM (National Library of Medicine)

bantry pharma, llc - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - this product is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water and xanthan gum. urea is a diamide of carbonic acid with the following chemical structure: for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

United States - English - NLM (National Library of Medicine)

palmetto pharmaceuticals inc. - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Australia - English - Department of Health (Therapeutic Goods Administration)

vitramed pty ltd - urea (14c), quantity: 37 kbq - capsule, hard - excipient ingredients: citric acid; titanium dioxide; indigo carmine; gelatin - helicap (urea[14c], 37kbq capsule) breath test is indicated for use in the detection of gastric urease as an aid in the diagnosis of h.pylori infection in the human stomach

United States - English - NLM (National Library of Medicine)

h2-pharma llc - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - droxia is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. droxia is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. droxia can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)] . there are no data with droxia use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis (see data) . advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with droxia. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m2 basis. hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) in rabbits. embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. hydroxyurea crosses the placenta. single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m2 basis) to rats caused growth retardation and impaired learning ability. hydroxyurea is excreted in human milk. because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during treatment with droxia. verify the pregnancy status of females of reproductive potential prior to initiating droxia therapy. droxia can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during and after treatment with droxia for at least 6 months after therapy. advise females to immediately report pregnancy. droxia may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and after treatment with droxia for at least 1 year after therapy [see nonclinical toxicology (13.1)] . based on findings in animals and humans, male fertility may be compromised by treatment with droxia. azoospermia or oligospermia, sometimes reversible, has been observed in men. inform male patients about the possibility of sperm conservation before the start of therapy [see adverse reactions (6) and nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients have not been established. clinical studies of droxia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients may be more sensitive to the effects of hydroxyurea and may require a lower dose regimen. hydroxyurea is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.2)] . the exposure to hydroxyurea is higher in patients with creatinine clearance of less than 60 ml/min. reduce dosage and closely monitor the hematologic parameters when droxia is to be administered to these patients [see dosage and administration (2.2) and clinical pharmacology (12.3)] . there are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. close monitoring of hematologic parameters is advised in these patients.

United States - English - NLM (National Library of Medicine)

medimetriks pharmaceuticals, inc. - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - urea 0.45 ml in 1 ml

United States - English - NLM (National Library of Medicine)

crown laboratories - urea (unii: 8w8t17847w) (urea - unii:8w8t17847w) - urea 400 mg in 1 g

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

am distributions (yorkshire) ltd - urea - cutaneous cream - 100mg/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

j m mcgill ltd - urea - cutaneous cream - 100mg/1gram

Australia - English - Department of Health (Therapeutic Goods Administration)

tri-med distributors pty ltd - urea (14c), quantity: 37 kbq - capsule, hard - excipient ingredients: fluorescein sodium; sucrose; maize starch; gelatin; silicon dioxide; sodium lauryl sulfate - pytest (urea [14c]breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of h. pylori infection in the human stomach.