TRIVIX- triamcinolone acetonide cream .1%, dimethicone 5% cream kit

Trivix by

Drug Labeling and Warnings

Trivix by is a Prescription medication manufactured, distributed, or labeled by Primary Pharmaceuticals, Inc., Biomed Laboratories, LLC., Perrigo Israel Pharmaceuticals LTD., Rainbow Gold. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Trivix- carton

INGREDIENTS AND APPEARANCE

TRIVIX 
triamcinolone acetonide cream .1%, dimethicone 5% cream kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72275-709

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72275-709-77	1 in 1 CARTON; Type 0: Not a Combination Product	08/01/2019

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

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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		80 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-152-44	118 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

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 - Primary Pharmaceuticals, Inc. (066126126)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories, LLC.		055329696	manufacture(53329-152)

Establishment
Name	Address	ID/FEI	Business Operations
Perrigo Israel Pharmaceuticals LTD.		600093611	manufacture(45802-064)

Establishment
Name	Address	ID/FEI	Business Operations
Rainbow Gold		800695152	repack(72275-709)