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THERA Dimethicone Body Shield (McKesson Medical-Surgical Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 118 mL in 1 TUBE (68599-0203-4) Label Information

Complete THERA Dimethicone Body Shield Information

  • Dimethicone, 118ml (68599-0203-4)


  • Active ingredient

    Dimethicone 5.0%


  • Purpose

    Skin Protectant


  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.


  • 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

  • Directions


    • Cleanse skin with THERA TM Moisturizing Body Cleanser or THERA TM Foaming Body Cleanser
    • Apply cream liberally until entire area is covered
    • Apply as needed

  • Other information

    • Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Lead Juice, SAFFLEX TM (Consisting of: Calcium Pantothenate (Vitamin B 5), Maltodextrin, Niacinamide (Vitamin B 3), Pyridoxine HCl (Vitamin B 6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tintorius (Safflower) Seed Oil, Cetyl Alcohol, Chlorphenesin, Dimethicone Crosspolymer, Disodium EDTA, Glycerin, Glyceryl Stearate, Lavender Ylang Fragrance, PEG-100 Stearate, Pentaery Tetra-di-t-Butyl Hydroxyhydrocinnamate, Phenoxyethanol, Purified Water, Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber (Ginger) Root Extract.


  • Trimcinolone Acetonide Cream USP, 80g (45802-064-36)


  • 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)]-(11ß16a). Its structural formula is:


    Triamcinolone Acetonide Structure

    Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 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.

    Each gram of Triamcinolone Acetonide Cream USP, 0.1 % 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.

    Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 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 & 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 PRECAUTIONS

    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 PATIENTS

    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 & 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 suppressionand 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


  • OVERDOSAGE

    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).


  • DOSAGE & 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 45802-064-36






    Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature].

    Avoid excessive heat. Protect from freezing.



    PRINTED IN USA



    Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645

    Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604



    P1810.01



    Revised: Sept 2015


  • Dimethicone PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image of 4 fl oz label


  • Trimcinolone Acetonide Cream USP PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PDP


  • NuTriaRX CreamPak PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PDP


  • INGREDIENTS AND APPEARANCE
    NUTRIARX CREAMPAK 
    riamcinolone acetonide, dimethicone kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70859-047
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70859-047-01 1 in 1 KIT 08/14/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 118 mL
    Part 2 1 TUBE 80 g
    Part 1 of 2
    THERA DIMETHICONE BODY SHIELD 
    dimethicone cream
    Product Information
    Item Code (Source) NDC:68599-0203
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GINGER (UNII: C5529G5JPQ)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-0203-4 118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/29/2016
    Part 2 of 2
    TRIAMCINOLONE ACETONIDE 
    triamcinolone acetonide cream
    Product Information
    Item Code (Source) NDC:45802-064
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE 1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBIC ACID (UNII: X045WJ989B)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-064-36 80 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA086413 09/28/2006
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA088042 07/29/2016
    Labeler - Nucare Pharmaceuticals, Inc. (010632300)
    Establishment
    Name Address ID/FEI Business Operations
    NuCare Pharmaceuticals,Inc. 010632300 manufacture(70859-047)