NDC 72275-739 Trivix Lite

Triamcinolone Acetonide Cream .1%

NDC Product Code 72275-739

NDC 72275-739-77

Package Description: 1 KIT in 1 CARTON * 80 g in 1 TUBE

NDC Product Information

Trivix Lite with NDC 72275-739 is a a human prescription drug product labeled by Primary Pharmaceuticals, Inc.. The generic name of Trivix Lite is triamcinolone acetonide cream .1%. The product's dosage form is kit and is administered via form.

Labeler Name: Primary Pharmaceuticals, Inc.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SORBIC ACID (UNII: X045WJ989B)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Primary Pharmaceuticals, Inc.
Labeler Code: 72275
FDA Application Number: ANDA086413 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-20-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Trivix Lite Product Label Images

Trivix Lite Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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, 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.

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 testACTH 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:BurningItchingIrritationDrynessFolliculitisHypertrichosisAcneiform eruptionsHypopigmentationPerioral dermatitisAllergic contact dermatitisMaceration of the skinSecondary infectionSkin AtrophyStriaeMiliaria

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.

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.

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