NuTriaRX CreamPak (Page 2 of 2)

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 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 and 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 four 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 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

SILICONE TAPE

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.

DIMETHICONE

PDP
(click image for full-size original)

TRIMCINOLONE ACETONIDE CREAM USP

PDP
(click image for full-size original)

NuTriaRX CreamPAK

PDP
(click image for full-size original)

NUTRIARX CREAMPAK triamcinolone acetonide, dimethicone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70859-054
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70859-054-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 118 mL
Part 2 1 TUBE 80 g
Part 1 of 2
DIMETHICONE body shield cream
Product Information
Item Code (Source) NDC:68599-0213
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
CETYL ALCOHOL
MALTODEXTRIN
LYSINE
SODIUM ASCORBYL PHOSPHATE
EDETATE DISODIUM ANHYDROUS
TYROSINE
ARGININE
KUKUI NUT OIL
SILICON DIOXIDE
TROLAMINE
PYRIDOXINE HYDROCHLORIDE
PHENOXYETHANOL
PEG-100 STEARATE
STEARIC ACID
NIACINAMIDE
CHLORPHENESIN
OCTENYLSUCCINIC ACID
ALOE VERA LEAF
LEVOMENOL
THREONINE
CAPRYLYL GLYCOL
ALANINE
GLYCERYL MONOSTEARATE
SAFFLOWER OIL
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
CALCIUM PANTOTHENATE
GLYCERIN
HYALURONATE SODIUM
GLUTAMIC ACID
ISOLEUCINE
BUTYLENE GLYCOL
VALINE
PHENYLALANINE
METHIONINE
SERINE
GLYCINE
ASPARTIC ACID
WATER
GINGER
.ALPHA.-TOCOPHEROL ACETATE
HISTIDINE
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES
PROLINE
LEUCINE
CYSTEINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68599-0213-4 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/12/2019
Part 2 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
CETYL ALCOHOL
POLYSORBATE 60
SORBITAN MONOSTEARATE
SORBIC ACID
CETYL ESTERS WAX
GLYCERIN
PROPYLENE GLYCOL
WATER
ISOPROPYL PALMITATE
GLYCERYL MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-064-36 1 TUBE in 1 CARTON contains a TUBE
1 80 g in 1 TUBE This package is contained within the CARTON (45802-064-36)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086413 09/28/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/28/2006
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 manufacture (70859-054)

Revised: 08/2021 NuCare Pharmaceuticals,Inc.

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