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TriHeal-80

Package insert / prescribing information
Generic name: triamcinolone acetonide, dimethicone
Dosage form: cream, kit
Drug class: Topical steroids with anti-infectives

Medically reviewed by Drugs.com. Last updated on Aug 1, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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, 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

TriHeal-80
triamcinolone acetonide cream .1%, dimethicone 5% cream kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:81877-508
Packaging
# Item Code Package Description
1 NDC:81877-508-80 1 KIT in 1 CARTON
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:45802-064
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
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL PALMITATE
POLYSORBATE 60
GLYCERIN
CETYL ESTERS WAX
PROPYLENE GLYCOL
WATER
GLYCERYL MONOSTEARATE
SORBIC ACID
CETYL ALCOHOL
SORBITAN MONOSTEARATE
Packaging
# Item Code Package Description
1 80 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086413 10/09/2006
Part 2 of 2
MEDLINE REMEDY PHYTOPLEX SKIN REPAIR
dimethicone cream
Product Information
Item Code (Source) NDC:53329-152
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
GELIDIELLA ACEROSA
METHYL DIHYDROJASMONATE (SYNTHETIC)
HONEY
ISOPROPYL MYRISTATE
HYDROLYZED JOJOBA ESTERS (ACID FORM)
SACCHAROMYCES CEREVISIAE
OMEGA-3 FATTY ACIDS
PHYTONADIONE
ORANGE OIL
CHOLECALCIFEROL
ETHYLENE BRASSYLATE
RAPESEED STEROL
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)
CORN OIL
GREEN TEA LEAF
CARTHAMUS TINCTORIUS SEED OLEOSOMES
.ALPHA.-TOCOPHEROL ACETATE, DL-
PEG-100 STEARATE
WATER
STEARIC ACID
OLIVE OIL
COCONUT OIL
GLYCERIN
HYDROXYACETOPHENONE
CLOVE
MANDARIN OIL
GRAPEFRUIT OIL
1,2-HEXANEDIOL
GLYCERYL MONOSTEARATE
PROPANEDIOL
CETYLHYDROXYPROLINE PALMITAMIDE
GLYCOL DISTEARATE
CAPRYLYL GLYCOL
HEXYLDECANOL
.BETA.-BISABOLOL
7-DEHYDROCHOLESTEROL
MEDIUM-CHAIN TRIGLYCERIDES
VANILLIN
Packaging
# Item Code Package Description
1 NDC:53329-152-44 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2019
Labeler - ForReal Pharmaceuticals (118029197)
ForReal Pharmaceuticals

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