Derma-smoothe/fs label

Derma-smoothe/fs

Derma-smoothe/fs Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Derma-Smoothe/FS® is a low to medium potency corticosteroid indicated:

In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).

History

There is currently no drug history available for this drug.

Other Information

Derma-Smoothe/FSTopical® Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Derma-Smoothe/FS® 0.01% fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:

Chemical Structure

Fluocinolone acetonide in Derma-Smoothe/FS® has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Derma-Smoothe/FS® contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances .

Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.

Derma-smoothe/fs Manufacturers

  • Hill Dermaceuticals, Inc.
    Derma-smoothe/fs | Hill Dermaceuticals, Inc.
    No Recall

    Derma-smoothe/fs | Hill Dermaceuticals, Inc.

    Derma-smoothe/fs | Hill Dermaceuticals, Inc.

    Derma-Smoothe/FS® for scalp psoriasis in adults (Scalp Oil):

    For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Derma-Smoothe/FS® on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.

  • Hill Dermaceuticals, Inc.
    Derma-smoothe/fs | Hill Dermaceuticals, Inc.
    No Recall

    Derma-smoothe/fs | Hill Dermaceuticals, Inc.

    Derma-smoothe/fs | Hill Dermaceuticals, Inc.

    Derma-Smoothe/FS® is not for oral, ophthalmic, or intravaginal use.

    The dosing of Derma-Smoothe/FS® is different for adult and pediatric patients.

    2.1 Adult Patients with Atopic Dermatitis

    Apply Derma-Smoothe/FS® as a thin film to the affected areas three times daily.

    2.2 Pediatric Patients with Atopic Dermatitis

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

  • Physicians Total Care, Inc.
    Derma-smoothe/fs | Physicians Total Care, Inc.
    No Recall

    Derma-smoothe/fs | Physicians Total Care, Inc.

    Derma-smoothe/fs | Physicians Total Care, Inc.

    Derma-Smoothe/FS® for scalp psoriasis in adults (Scalp Oil):

    For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Derma-Smoothe/FS® on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.

  • Derma-smoothe/fs | Royal Pharmaceuticals
    No Recall

    Derma-smoothe/fs | Royal Pharmaceuticals

    Derma-smoothe/fs | Royal Pharmaceuticals

    Derma-Smoothe/FS® is not for oral, ophthalmic, or intravaginal use.

    The dosing of Derma-Smoothe/FS® is different for adult and pediatric patients.

    2.1 Adult Patients with Atopic Dermatitis

    Apply Derma-Smoothe/FS® as a thin film to the affected areas three times daily.

    2.2 Pediatric Patients with Atopic Dermatitis

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

  • Derma-smoothe/fs | Royal Pharmaceuticals
    No Recall

    Derma-smoothe/fs | Royal Pharmaceuticals

    Derma-smoothe/fs | Royal Pharmaceuticals

    Derma-Smoothe/FS® for scalp psoriasis in adults (Scalp Oil):

    For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Derma-Smoothe/FS® on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.