of issues of safety DermasilkRx SDSPak Generic Name: triamcinolone acetonide cream, dimethicone cream Dosage Form: kit Triamcinolone Acetonide Cream USP (0.1%) DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is: Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. 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. Corticosteriods 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 Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS Triamcinolone acetonide cream 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 which 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. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. 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 not 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, Cushings'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 Miliaria DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted. HOW SUPPLIED Triamcinolone acetonide cream USP 0.1% is supplied in 80 g tube NDC 67877-251-80 Store at 59-86 F. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION. Skin Repair Complex (Dimethicone 5.0%) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions apply cream liberally as needed Other information protect from freezing avoid excessive heat Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine. Silicone Tape Uses To be applied to wounds or scars as a protective silicone barrier. As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions Do not use if you are allergic to silicone Keep out of reach of children Directions for use Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours. SDS pak- carton DermasilkRx SDSPak triamcinolone acetonide cream, dimethicone cream kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69329-250 Packaging # Item Code Package Description 1 NDC:69329-250-01 1 KIT in 1 PACKAGE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 80 g Part 2 1 TUBE 118 mL Part 1 of 2 TRIAMCINOLONE ACETONIDE triamcinolone acetonide cream Product Information Item Code (Source) NDC:67877-251 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 1 mg in 1 g Packaging # Item Code Package Description 1 1 TUBE in 1 KIT 1 NDC:67877-251-80 80 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088042 Part 2 of 2 SKIN REPAIR COMPLEX dimethicone cream Product Information Item Code (Source) NDC:69329-253 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (DIMETHICONE) DIMETHICONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID TROLAMINE Packaging # Item Code Package Description 1 1 TUBE in 1 KIT 1 NDC:69329-253-02 118 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088042 07/20/2015 Labeler - Patchwerx Labs, Inc. 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