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

TRIMCINOLONE ACETONIDE CREAM USP

NuTriaRX CreamPAK

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.