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Pandel Indications, Dosage, Storage, Stability - Hydrocortisone Probutate Cream

Pandel Indications, Dosage, Storage, Stability - Hydrocortisone Probutate Cream

INDICATIONS

Pandel® (hydrocortisone probutate cream) Cream, 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses in patients 18 years of age or older.

Pandel® (hydrocortisone probutate cream) Cream, 0.1% is contraindicated in those patients who are hypersensitive to hydrocortisone probutate or to any of the components of the preparation.

DOSAGE AND ADMINISTRATION

Apply a thin film of Pandel® (hydrocortisone probutate cream) Cream, 0.1% to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.

Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Pandel® (hydrocortisone probutate cream) Cream, 0.1% should not be used with occlusive dressings unless directed by the physician. Pandel® (hydrocortisone probutate cream) Cream, 0.1% should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

HOW SUPPLIED

Pandel® (hydrocortisone probutate cream) Cream, 0.1%, a white to off-white opaque cream is supplied as follows:

15 g tubes (NDC 0281-0153-15),
45 g tubes (NDC 0281-0153-46), and
80 g tubes (NDC 0281-0153-80)

Storage: Store at controlled room temperature 15°-30°C (59°-86°F).

CAUTION: Federal law prohibits dispensing without prescription.

REFERENCE

1. Data on file, Savage Laboratories.

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