Prescription Drug Name:
Triamcinolone Acetonide Cream USP
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Triamcinolone Acetonide Cream USP 0.025% contains: 0.25 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.
Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
displayName: PHARMACOKINETICS SECTION
FDA Article Code: 43682-4
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
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
Information for the Patient
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0
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.
displayName: LABORATORY TESTS SECTION
FDA Article Code: 34075-2
Carcinogenesis, Mutagenesis, and Impairment of Fertility
displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6
Pregnancy: Teratogenic Effects –
displayName: PREGNANCY SECTION
FDA Article Code: 42228-7
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 no 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.
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply Triamcinolone Acetonide Cream 0.1%, as appropriate, to the affected area two to three times daily. Rub in gently.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
15 gram tubes
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7
Avoid excessive heat. Protect from freezing.
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4