DESCRIPTIONTriamcinolone Acetonide Cream USP containstriamcinolone acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21- dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-],with the empirical formula C24H31FO6 andmolecular weight 434.50. CAS 76-25-5.

Triamcinolone Acetonide Cream USP 0.025%contains: 0.25 mg of triamcinolone acetonideUSP per gram in a water washable cream baseconsisting of mineral oil (and) lanolin alcohol,isopropyl palmitate NF, propylene glycolstearate, propylene glycol USP, cetyl alcohol NF,sorbitan monostearate NF, polysorbate 60 NF,sorbic acid NF, polyoxyl (40) stearate NF,propylparaben NF, methylparaben NF andpurified water USP.

Triamcinolone Acetonide Cream USP 0.1%contains: 1 mg of triamcinolone acetonide USPper gram in a water washable cream baseconsisting of mineral oil (and) lanolin alcohol,isopropyl palmitate NF, propylene glycolstearate, propylene glycol USP, cetyl alcohol NF,sorbitan monostearate NF, polysorbate 60 NF,sorbic acid NF, polyoxyl (40) stearate NF,propylparaben NF, methylparaben NF andpurified water USP.

CLINICAL PHARMACOLOGYTopical corticosteroids share anti-inflammatory,anti-pruritic and vasoconstrictive actions. Themechanism of anti-inflammatory activity of thetopical corticosteroids is unclear. Variouslaboratory methods, including vasoconstrictorassays, are used to compare and predictpotencies and/or clinical efficacies of the topicalcorticosteroids. There is some evidence tosuggest that a recognizable correlation existsbetween vasoconstrictor potency andtherapeutic efficacy in man.

PharmacokineticsThe extent of percutaneous absorption oftopical corticosteroids is determined by manyfactors including the vehicle, the integrity of theepidermal barrier, and the use of occlusivedressings. Topical corticosteroids can beabsorbed from normal intact skin. Inflammationand/or other disease processes in the skinincrease percutaneous absorption. Occlusivedressings substantially increase thepercutaneous absorption of topical cortico-steroids. Thus, occlusive dressings may be avaluable therapeutic adjunct for treatment of

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resistant dermatoses (See DOSAGE ANDADMINISTRATION). Once absorbed throughthe skin, topical corticosteroids are handledthrough pharmacokinetic pathways similar tosystemically administered corticosteroids.Corticosteroids are bound to plasma proteins invarying degrees. Corticosteroids aremetabolized primarily in the liver and are thenexcreted by the kidneys. Some of the topicalcorticosteroids and their metabolites are alsoexcreted into the bile.

INDICATIONS AND USAGETopical corticosteroids are indicated for therelief of the inflammatory and pruriticmanifestations of corticosteroid-responsivedermatoses.

CONTRAINDICATIONSTopical corticosteroids are contraindicated inthose patients with a history of hypersensitivityto any of the components of the preparation.

PRECAUTIONSGeneralSystemic absorption of topical corticosteroidshas produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestationsof Cushing's syndrome, hyperglycemia, andglucosuria in some patients. Conditions whichaugment systemic absorption include theapplication of the more potent steroids, useover large surface areas, prolonged use, andthe addition of occlusive dressings. Therefore,patients receiving a large dose of a potenttopical steroid applied to a large surface area orunder an occlusive dressing should beevaluated periodically for evidence of HPA axissuppression by using the urinary free cortisoland ACTH stimulation tests. If HPA axissuppression is noted, an attempt should bemade to withdraw the drug, to reduce thefrequency of application, or to substitute a lesspotent steroid. Recovery of HPA axis function isgenerally prompt and complete upondiscontinuation of the drug.

Infrequently, signs and symptoms of steroidwithdrawal may occur, requiring supplementalsystemic corticosteroids. Children may absorbproportionally larger amounts of topicalcorticosteroids and thus be more susceptible tosystemic toxicity (See PRECAUTIONS-PediatricUse). If irritation develops, topical cortico-steroids should be discontinued andappropriate therapy instituted. In the presenceof dermatological infections, the use of anappropriate anti-fungal or antibacterial agentshould be instituted. If a favorable responsedoes not occur promptly, the corticosteroidshould be discontinued until the infection hasbeen adequately controlled.

Information for the PatientPatients using topical corticosteroids should

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TRIAMCINOLONEACETONIDECREAMUSPFOREXTERNALUSEONLY

NOTFOROPHTHALMICUSERxonly

TRIAMCINOLONE ACETONIDE CREAM USPFOR EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USERx only

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receive the following information andinstructions.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 thismedication for any disorder other than forwhich it was prescribed.

3. The treated skin area should not bebandaged or otherwise covered or wrappedas to be occlusive unless directed by thephysician.

4. Patients should report any signs of localadverse reactions especially under occlusivedressing.

5. Parents of pediatric patients should beadvised not to use tight fitting diapers orplastic pants on a child being treated in thediaper area, as these garments mayconstitute occlusive dressings.

Laboratory TestsThe following tests may be helpful in evaluatingthe HPA axis suppression: Urinary free cortisoltest; ACTH stimulation test.

Carcinogenesis, Mutagenesis, andImpairment of FertilityLong-term animal studies have not beenperformed to evaluate the carcinogenicpotential or the effect on fertility of topicalcorticosteroids. Studies to determinemutagenicity with prednisolone and hydro-cortisone have revealed negative results.

Pregnancy: Teratogenic Effects -Pregnancy Category CCorticosteroids are generally teratogenic inlaboratory animals when administeredsystemically at relatively low dosage levels. Themore potent corticosteroids have been shownto be teratogenic after dermal application inlaboratory animals. There are no adequate andwell-controlled studies in pregnant women onteratogenic effects from topically appliedcorticosteroids. Therefore, topical cortico-steroids should be used during pregnancy only ifthe potential benefit justifies the potential risk tothe fetus. Drugs of this class should not beused extensively on pregnant patients, in largeamounts, or for prolonged periods of time.

Nursing MothersIt is not known whether topical administration ofcorticosteroids could result in sufficientsystemic absorption to produce detectablequantities in breast milk. Systemicallyadministered corticosteroids are secreted intobreast milk in quantities not likely to have adeleterious effect on the infant. Nevertheless,caution should be exercised when topicalcorticosteroids are administered to a nursingwoman.

Pediatric UsePediatric patients may demonstrate greatersusceptibility to topical corticosteroid-inducedHPA axis suppression and Cushing's syndromethan mature patients because of a larger skinsurface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression,

Cushing's syndrome, and intracranialhypertension have been reported in childrenreceiving topical corticosteroids. Manifestationsof adrenal suppression in children include lineargrowth retardation, delayed weight gain, lowplasma cortisol levels, and absence of responseto ACTH stimulation. Manifestations ofintracranial hypertension include bulgingfontanelles, headaches, and bilateralpapilledema. Administration of topicalcorticosteroids to children should be limited tothe least amount compatible with an effectivetherapeutic regimen. Chronic corticosteroidtherapy may interfere with the growth anddevelopment of children.

ADVERSE REACTIONSThe following local adverse reactions arereported infrequently with topical cortico-steroids, but may occur more frequently withthe use of occlusive dressings. These reactionsare listed in an approximate decreasing order ofoccurrence: burning, itching, irritation, dryness,folliculitis, hypertrichosis, acneiform eruptions,hypopigmentation, perioral dermatitis, allergiccontact dermatitis, maceration of the skin,secondary infection, skin atrophy, striae andmiliaria.

To report SUSPECTED ADVERSE REACTIONS,contact G&W Laboratories, Inc. at1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGETopically applied corticosteroids can beabsorbed in sufficient amounts to producesystemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATIONApply Triamcinolone Acetonide Cream USP0.025% to the affected area two to four timesdaily. Rub in gently.

Apply the 0.1% Triamcinolone AcetonideCream, as appropriate, to the affected area twoto three times daily. Rub in gently.

Occlusive dressings may be used for themanagement of psoriasis or recalcitrantconditions. If an infection develops, the use ofocclusive dressings should be discontinued andappropriate antimicrobial therapy instituted.

HOW SUPPLIEDTriamcinolone Acetonide Cream USP 0.025%15 gram tubes NDC 0713-0226-1580 gram tubes NDC 0713-0226-80

Triamcinolone Acetonide Cream USP 0.1%15 gram tubes NDC 0713-0225-1530 gram tubes NDC 0713-0225-3180 gram tubes NDC 0713-0225-80

STORAGEStore at 20-25°C (68-77°F) [see USPControlled Room Temperature].Keep out of reach of children.Avoid excessive heat. Protect from freezing.

Manufactured by:G&W Laboratories, Inc.111 Coolidge StreetSouth Plainfield, NJ 07080

Rev. 06/20158-TRIACRGW3