is generally Dermasorb HC Generic Name: hydrocortisone Dosage Form: lotion with shampoo and body wash kit Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Dermasorb HC COMPLETE KIT Dermasorb HC Description The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11ß). Its structural formula is: Each mL of DERMASORB HC (Hydrocortisone USP, 2%) Lotion contains 20 mg hydrocortisone USP in a lotion base consisting of water, isopropyl alcohol, polysorbate 20, propylene glycol, and benzalkonium chloride. Slideshow 7 First Aid Kit Must Haves For Your Medicine Cabinet Dermasorb HC - Clinical Pharmacology Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Indications and Usage for Dermasorb HC DERMASORB HC lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Contraindications DERMASORB HC lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Precautions General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing s syndrome, hyperglycemia, and glucosuria in some patients. Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing s syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children. Adverse Reactions The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin Atrophy, Striae, and Miliaria. Overdosage Topically applied corticosteroids can be absorbed in sufficient amounts to produce systems effects (See PRECAUTIONS ). Dermasorb HC Dosage and Administration Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. PACKAGING AND STORAGE: Store at room temperature 15 C- 30 C (59 F - 86 F) in original container. Protect from freezing. HOW SUPPLIED: DERMASORB HC (Hydrocortisone USP, 2%) Lotion is supplied in: 1 fluid ounce (29.6 ml) bottle NDC 0316-0201-01 Rx Only PRINTED IN USA P6171.01 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN, 37604 Dermasorb HC Complete Kit p617201 Established Pharmacological Class Substance Pharmacological Class Dermasorb Shampoo and Body Wash Shampoos (non-coloring) Dermasorb HC COMPLETE KIT hydrocortisone lotion with shampoo and body wash kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-1005 Packaging # Item Code Package Description 1 NDC:0316-1005-01 1 KIT in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BOTTLE, DROPPER 59.2 mL Part 2 1 BOTTLE, PLASTIC 236.6 mL Part 1 of 2 Dermasorb HC hydrocortisone lotion lotion Product Information Item Code (Source) NDC:0316-0201 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 PROPYLENE GLYCOL ISOPROPYL ALCOHOL BENZALKONIUM CHLORIDE WATER Packaging # Item Code Package Description 1 NDC:0316-0201-01 2 BOTTLE, DROPPER in 1 KIT 1 29.6 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA083231 11/14/2013 Part 2 of 2 DERMASORB SHAMPOO AND BODY WASH Product Information Ingredients Ingredient Name Quantity AMMONIUM LAURETH-2 SULFATE WATER GLYCOLIC ACID GLYCERIN DISODIUM COCOAMPHODIACETATE AMMONIUM GLYCOLATE MENTHOL PROPYLENE GLYCOL DIAZOLIDINYL UREA METHYLPARABEN PROPYLPARABEN Packaging # Item Code Package Description 1 1 BOTTLE, PLASTIC in 1 KIT 1 236.6 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 11/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA083231 11/14/2013 Labeler - Crown Laboratories (079035945) Registrant - Crown Laboratories (079035945) Establishment Name Address ID/FEI Operations Crown Laboratories 079035945 manufacture(0316-1005) Revised: 11/2013 Crown Laboratories Next Interactions Print this page Add to My Med List More about Dermasorb HC (hydrocortisone topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical steroids Consumer resources Dermasorb HC Dermasorb HC Complete Kit (Advanced Reading) Professional resources Hydrocortisone topical (AHFS Monograph) Hydrocortisone in Absorbase (FDA) Other brands: Proctozone HC , Westcort , Anucort-HC , Proctocort , ... +18 more Other Formulations Dermasorb XM Dermasorb AF Related treatment guides Eczema Atopic Dermatitis Dermatitis Intertrigo ... +4 more} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical steroids Related Drugs topical steroids fluticasone topical , triamcinolone topical , hydrocortisone topical , clobetasol topical Eczema prednisone , fluticasone topical , triamcinolone topical , hydrocortisone topical , dexamethasone , clobetasol topical , More... 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