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TRIAMCINOLONE ACETONIDE CREAM 0.1% 30 G - 1 mg/g CREAM
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TRIAMCINOLONE ACETONIDE CREAM 0.1% 30 G

Generic: Triamcinolone Acetonide

TRIAMCINOLONE ACETONIDE CREAM 0.1% 30 G

NDC:51672-1282-02
Manufacturer:Sun Pharmaceutical Industries, Inc.
Strength:1 mg/g
Dosage Form:CREAM
Route:TOPICAL

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Drug Information

Identification

Generic Name

Triamcinolone Acetonide

Brand Name

Triamcinolone Acetonide

Labeler / Distributor

Sun Pharmaceutical Industries, Inc.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

CREAM

Route of Administration

TOPICAL

FDA Application Number

ANDA040039

Active Ingredients

IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Pharmacological Class

Corticosteroid Hormone Receptor Agonists [MoA]Corticosteroid

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

INDICATIONS AND USAGE Triamcinolone acetonide cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply triamcinolone acetonide cream USP, 0.1% as appropriate, to the affected area two to three times daily. Rub in gently. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide cream USP, 0.1% under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Adverse Reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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.

Information for Patients

Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. 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.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.