PrDerma-Smoothe/FS ®
Fluocinolone acetonide Topical Oil 0.01% w/v
Topical Use – for the Body only
Derma-Smoothe/FS® Topical Oil is indicated for the treatment of atopic eczema in adults. Derma-Smoothe/FS® Topical Oil is also indicated for the treatment of atopic dermatitis in children 3 months to 12 years. Derma-Smoothe/FS® Topical Oil is not to be used on the face or in the diaper or anogenital area. It may be used for a maximum of 4 weeks on the body. Derma-Smoothe/FS® Topical Oil should not be used on infants under the age of 3 months.
Derma-Smoothe/FS® is a topical corticosteroid, which reduces inflammation (swelling), redness and itching.
Do not use Derma-Smoothe/FS® Topical Oil if you (or your child):
Do not apply Derma-Smoothe/FS® Topical Oil in or near the eye.
Fluocinolone acetonide
Refined Peanut Oil NF, Mineral Oil Light, Oleth-2, Isopropyl Myristate, Isopropyl Alcohol, Cream Fragrance, and Balsam Pine Fragrance.
The peanut oil used in Derma-Smoothe/FS® is tested for residual protein through amino acid analysis; the acceptance criterion for total protein is no more than 0.5 parts per million.
Topical Oil
Derma-Smoothe/FS® Topical Oil is provided in two packaging configurations. The composition of both packaging configurations are identical:
Topical corticosteroids when used over large areas for prolonged periods and under an occlusive dressing can be absorbed into the bloodstream and cause reversible adrenal suppression. Children and infants are particularly susceptible to adrenal suppression related to use of topical corticosteroids.
Before using Derma-Smoothe/FS® Topical Oil, talk to your doctor or pharmacist if:
Avoid getting Derma-Smoothe/FS® Topical Oil in the eye, or other mucous membrane.
Do not use occlusive dressings such as a bandage, or cover the treated areas tightly.
Derma-Smoothe/FS® Topical Oil should not be used to treat diaper dermatitis. Derma-Smoothe/FS® Topical Oil should not be applied to the diaper area as diapers or plastic pants may constitute occlusive dressing.
Derma-Smoothe/FS® Topical Oil should be used with caution on the underarm or groin. This medication is not recommended for use on the face.
If you are over 65 years of age, use Derma-Smoothe/FS® Topical Oil with caution.
Tell your doctor or pharmacist about all your other medications, including medicines that you bought without a prescription and natural health products. Especially if you are taking the following medications:
Since it is not known if Derma-Smoothe/FS® Topical Oil can be used with other treatments, it is recommended that Derma-Smoothe/FS® not be used with other treatments.
Not for oral, ophthalmic, or intravaginal use.
Apply the least amount of Derma-Smoothe/FS® Topical Oil needed to cover the affected area. Avoid contact with the eyes. In case of contact, wash eyes liberally with water. Do not use Derma-Smoothe/FS® Topical Oil with occlusive dressings, diapers or plastic pants.
Moisten the affected area with water. Apply a thin film of Derma-Smoothe/FS® Topical Oil to the affected area and massage in gently. Use two to three times daily. For use on the scalp: Wet hair and scalp, then apply thin film of oil to entire scalp. Massage scalp and cover with supplied shower cap overnight (4 hours minimum).
Moisten the affected area with water. Apply a thin film of Derma-Smoothe/FS® Topical Oil to the affected area and massage in gently. Use twice daily for a maximum of 4 weeks. Do not use on the face or in the diaper or anogenital area. If no improvement is seen within 2 weeks, contact your child’s doctor.
If you have applied more Derma-Smoothe/FS® Topical Oil than you should, wash thoroughly with water and contact your doctor or your nearest poison control centre, or go to the emergency room of your local hospital.
If a dose of this medication is missed, it is not necessary to make up the missed dose. Skip the missed dose and continue with the next scheduled dose.
Common side effects with Derma-Smoothe/FS® Topical Oil include:
There have been reports of reactions to Derma-Smoothe/FS® Topical Oil in children thought to be related to peanut allergy.
Other side effects reported with the use of topical corticosteroids in general include:
Serious side effects such as Cushing’s syndrome (a hormonal disorder) may be associated with systemic absorption from improper or excessive use of topical corticosteroids. Adrenal suppression, linear growth retardation, delayed weight gain and intracranial hypertension (increased pressure around the brain) have also been reported with the use of topical corticosteroids in infants and children.
Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Keep out of the reach of children and pets.
Medicines should not be disposed of down the drain or in household garbage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
