Label: TRIADIME-80- triamcinolone acetonide cream .1%, dimethicone 5% cream kit

  • NDC Code(s): 53329-152-44, 81877-509-80
  • Packager: ForReal Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 28, 2021

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  • 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:

    structure

    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, anti-pruritic 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
    24 31 6
    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

    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.

    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 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 45802-064-36

    Store at 59-86°F.

    CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

  • MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- (Dimethicone 5.0%)

    Drug Facts

    Active ingredient

    Dimethicone 5.0%

    Purpose

    Skin Protectant

    Uses


    ■ Temporarily protects and helps relieve chapped or cracked skin
    ■ Beneficial for face, hands, body and legs.

    Warnings

    For external use only

    Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns

    When using this product
    avoid contact with eyes.


    Stop use and ask a doctor if

    condition worsens
    symptoms last for 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


    Purified Water, Cocos Nucifera (Coconut oil), Olea Europaea (Olive Oil ), Cetyl Alcohol, Glyceryl
    stearate, Stearic Acid, Peg 100 stearate,Propanediol, Glycol Distearate,1,2- Hexanediol, Caprylyl
    Glycol, Hydroyacetophenone, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Sinensis (Orange) Peel Oil,
    Citrus Reticulata (Tangerine) Peel Oil, Hexyldecanol, Bisabolol, Cetylhydroxyproline Palmitamide,
    Brassica Campestris (Rapeseed) Sterols, Yeast Ferment Extract, Hydrolyzed Soy Protein, 7-
    Dehydrocholestrol, Caprylic/Capric Triglcerides, Glycerin, Phospholipids, Tocopherol Acetate,
    Algae Extract, Eugenia Caryophyllus (Clove) Flower Extract, Camellia Sinensis (Green Tea) Leaf
    Extract, Isopropyl Myristate, Methyldihydrojasmonate, Ethylene Brassylate, Vanilla Planifolia Extract,
    Carthamus Tinctorius (Safflower) Oleosomes, Manuka Honey, Cholecalciferol, Phytonadione, Jojoba
    Esters, Zea Mays (Corn) Oil

  • 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.

  • TriHeal 80- carton

    Packaged For:

    Forreal Pharmaceuticals LLC

    Royal Oak, MI 48067

    Question or Comments please call 877-367-3250

    label

  • INGREDIENTS AND APPEARANCE
    TRIADIME-80 
    triamcinolone acetonide cream .1%, dimethicone 5% cream kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81877-509
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-509-801 in 1 CARTON; Type 0: Not a Combination Product08/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 80 g
    Part 21 TUBE 118 mL
    Part 1 of 2
    TRIAMCINOLONE ACETONIDE 
    triamcinolone acetonide cream
    Product Information
    Item Code (Source)NDC:45802-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBIC ACID (UNII: X045WJ989B)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    180 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08641310/09/2006
    Part 2 of 2
    MEDLINE REMEDY PHYTOPLEX SKIN REPAIR 
    dimethicone cream
    Product Information
    Item Code (Source)NDC:53329-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GELIDIELLA ACEROSA (UNII: T91K54D6M1)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    HONEY (UNII: Y9H1V576FH)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    PHYTONADIONE (UNII: A034SE7857)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    CORN OIL (UNII: 8470G57WFM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CLOVE (UNII: K48IKT5321)  
    MANDARIN OIL (UNII: NJO720F72R)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-152-44118 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2019
    Labeler - ForReal Pharmaceuticals (118029197)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teligent011036910manufacture(81877-509)