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Derma-Smoothe FS

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Derma-Smoothe/FS

INDICATIONS

Adult Patients with Atopic Dermatitis

Derma-Smoothe/FS® (fluocinolone acetonide) is indicated for the topical treatment of atopic dermatitis in adult patients.

Pediatric Patients with Atopic Dermatitis

Derma-Smoothe/FS® (fluocinolone acetonide) is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

Limitations of Use

Apply the least amount of Derma-Smoothe/FS® (fluocinolone acetonide) needed to cover the affected areas. As with other corticosteroids, Derma-Smoothe/FS® (fluocinolone acetonide) should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Derma-Smoothe/FS (fluocinolone acetonide) should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.

Derma-Smoothe/FS (fluocinolone acetonide) should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see ADVERSE REACTIONS and Use in Specific Populations].

DOSAGE AND ADMINISTRATION

Derma-Smoothe/FS (fluocinolone acetonide) is not for oral, ophthalmic, or intravaginal use.

The dosing of Derma-Smoothe/FS (fluocinolone acetonide) is different for adult and pediatric patients.

Adult Patients with Atopic Dermatitis

Apply Derma-Smoothe/FS (fluocinolone acetonide) as a thin film to the affected areas three times daily.

Pediatric Patients with Atopic Dermatitis

Moisten skin and apply Derma-Smoothe/FS (fluocinolone acetonide) as a thin film to the affected areas twice daily for up to four weeks.

HOW SUPPLIED

Dosage Forms And Strengths

Derma-Smoothe/FS® (fluocinolone acetonide), Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.

Derma-Smoothe/FS (fluocinolone acetonide) is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC # 28105-150-04).

Storage:

Store at 25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773. Date: 12/2007. FDA Rev date: 12/12/2007

Last reviewed on RxList: 1/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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