Details for: DERMA SMOOTHE/FS LIQ 0.01%
Company: HILL DERMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00873292 | DERMA SMOOTHE/FS LIQ 0.01% | FLUOCINOLONE ACETONIDE | 0.01 % | EMULSION | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
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.
What it does
Derma-Smoothe/FS® is a topical corticosteroid, which reduces inflammation (swelling), redness and itching.
When it should not be used
Do not use Derma-Smoothe/FS® Topical Oil if you (or your child):
- are allergic to fluocinolone acetonide, other corticosteroids, or to any of the other ingredients in Derma-Smoothe/FS® Topical Oil. Derma-Smoothe/FS® Topical Oil contains refined peanut oil.
- have viral (e.g. herpes simplex, chickenpox), bacterial, fungal or parasitic infections, or skin changes related to tuberculosis infection, syphilis or vaccinations.
Do not apply Derma-Smoothe/FS® Topical Oil in or near the eye.
What the medicinal ingredient is
Fluocinolone acetonide
What the non-medicinal ingredients are
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.
What dosage form it comes in
Topical Oil
Derma-Smoothe/FS® Topical Oil is provided in two
packaging configurations. The composition of both
packaging configurations are identical:
- Derma-Smoothe/FS® Topical Oil, Topical Use – for the Body only, is supplied in bottles containing 118.28ml (4 fl. oz.).
- Derma-Smoothe/FS® Topical Oil, Topical Use – for the Scalp only, is supplied in bottles containing 118.28ml (4 fl. oz.) with shower cap included.
Warnings and precautions
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:
- your child is between 3 months and one year of age.
- you or your child has a peanut allergy or sensitivity.
- you have other inflammatory skin diseases as a result of impaired circulation (stasis dermatitis).
- you are pregnant or planning to become pregnant.
- you are breast feeding.
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.
Interactions with this medication
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:
- insulin, or medications for high blood sugar,
- diuretics (water pills),
- amphotericin-B (an anti-fungal medication),
- non-steroidal anti-inflammatory medications, salicylates (e.g. aspirin),
- blood thinning medications,
- estrogen,
- phenobarbital or phenytoin (anti-seizure medications)
- rifampin (antibiotic).
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.
Proper use of this medication
Not for oral, ophthalmic, or intravaginal use.
Usual dose
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.
For Adult Atopic Eczema:
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).
For Atopic Dermatitis in Children 3 months to 12 years.
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.
Overdose
Missed Dose
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.
Side effects and what to do about them
Common side effects with Derma-Smoothe/FS® Topical Oil include:
- redness, burning, itching, irritation, rash
- loss of skin colour (hypopigmentation)
- darkening of skin colour (hyperpigmentation)
- abscess (skin infection)
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:
- dryness, inflammation of hair follicles, abnormal hair growth
- stretch marks
- secondary infection, acne
- allergic skin reaction
- miliaria (heat rash)
- skin thinning
- rash around the mouth
- increased blood sugar
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.
| Symptom / effect
There have been no reported Serious Side Effects during clinical trials. |
Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist | Allergic Reaction: Failure to heal or flare up of existing condition, new rash, hives, swelling of mouth or tongue. |
✔ |
|---|---|---|---|
| Cushing's syndrome: associated with systemic absorption from improper or excessive use of topical corticosteroids. | ✔ | ||
| Severe headache or change in vision/double vision in children or abnormal bulging of the soft spots of the head (fontanelles) in infants. | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking Derma-Smoothe/FS® Topical Oil, contact your doctor or pharmacist.
How to store
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.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
This document plus the full product monograph,
prepared for health professionals can be found by
contacting the sponsor:
Hill Dermaceuticals, Inc.
At: 1-800-344-5707
This leaflet was prepared by Hill Dermaceuticals, Inc.
Last revised: May 10, 2018