HYDROCORTISONE BUTYRATE CREAM USP, 0.001 15 G
Generic: Hydrocortisone Butyrate
HYDROCORTISONE BUTYRATE CREAM USP, 0.001 15 G
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Identification
Hydrocortisone Butyrate
Hydrocortisone Butyrate
Taro Pharmaceuticals U.S.A., Inc.
HUMAN PRESCRIPTION DRUG
Administration
CREAM
TOPICAL
ANDA076654
Active Ingredients
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE BUTYRATE | 1 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone Butyrate Ointment, 0.1% and Hydrocortisone Butyrate Cream USP, 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Hydrocortisone Butyrate Topical Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION Hydrocortisone Butyrate Ointment, 0.1% or Hydrocortisone Butyrate Cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. 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. Hydrocortisone Butyrate Topical Solution, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
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. 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.
Information for Patients
Information for Patients 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 external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that 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.