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NuTriaRx

Generic Name: triamcinolone acetonide, dimethicone
Dosage Form: cream pak

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 (67877-251-80)

NuTriaRx 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:




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.

NuTriaRx - 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 is NuTriaRx Supplied

Triamcinolone acetonide cream USP 0.1% is supplied in
15 g tube NDC 67877-251-15
30 g tube NDC 67877-251-30
80 g tube NDC 67877-251-80
454 g jar NDC 67877-251-45

Triamcinolone acetonide cream USP 0.025% is supplied in
15 g tube NDC 67877-317-15
80 g tube NDC 67877-317-80
454 g jar NDC 67877-317-45

Triamcinolone acetonide cream USP 0.5% is supplied in
15 g tube NDC 67877-318-15

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

Trimcinolone Acetonide Cream USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67877-251-80
Triamcinolone Acetonide Cream USP, 0.1%
Ascend Laboratories LLC

80 gm

NuTriaRx CreamPak

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NuTriaRx CREAMPAK 
triamcinolone acetonide, dimethicone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70859-002
Packaging
# Item Code Package Description
1 NDC:70859-002-01 1 KIT in 1 KIT
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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
KUKUI NUT OIL  
ALOE VERA LEAF  
CALCIUM PANTOTHENATE  
MALTODEXTRIN  
NIACINAMIDE  
PYRIDOXINE HYDROCHLORIDE  
SILICON DIOXIDE  
SODIUM ASCORBYL PHOSPHATE  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
LEVOMENOL  
BUTYLENE GLYCOL  
CAPRYLYL GLYCOL  
SAFFLOWER OIL  
CETYL ALCOHOL  
CHLORPHENESIN  
EDETATE DISODIUM  
GLYCERIN  
GLYCERYL MONOSTEARATE  
PEG-100 STEARATE  
PHENOXYETHANOL  
WATER  
HYALURONATE SODIUM  
STEARIC ACID  
TROLAMINE  
GINGER  
Packaging
# Item Code Package Description
1 NDC:68599-0203-4 118 mL in 1 TUBE
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:67877-251    
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
MINERAL OIL  
PROPYLENE GLYCOL  
SORBITOL  
CETYL PALMITATE  
SORBIC ACID  
POTASSIUM SORBATE  
WATER  
Packaging
# Item Code Package Description
1 NDC:67877-251-80 80 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088042 07/29/2016
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)
Revised: 08/2016
 
Nucare Pharmaceuticals Inc
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