Derma-Smoothe / Fs Body Oil
It is used to treat eczema.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Derma-Smoothe/FS Body Oil is a medication that contains a strong steroid called fluocinolone. It is used on the skin to reduce redness, itching, and swelling caused by skin conditions like psoriasis and eczema (atopic dermatitis). It works by calming down the immune response in the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. However, if the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
When applying the medication to a hairy area, part the hair to ensure the medication reaches the affected skin.
Special Precautions
Avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this may increase the amount of medication absorbed into the body.
Unless directed by your doctor, do not apply the medication to the face, groin, armpits, or other skin folds.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. However, if the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
When applying the medication to a hairy area, part the hair to ensure the medication reaches the affected skin.
Special Precautions
Avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this may increase the amount of medication absorbed into the body.
Unless directed by your doctor, do not apply the medication to the face, groin, armpits, or other skin folds.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin film of the oil to the affected skin areas as directed by your doctor. Do not use more than prescribed.
- Gently rub the oil into the skin until it disappears.
- For scalp psoriasis, apply at bedtime and wash hair in the morning. For body use, leave on as directed.
- Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid getting the oil in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Wash your hands thoroughly after applying the medication.
- Do not use this medication for longer than prescribed, especially on children, as prolonged use can lead to side effects.
- Inform your doctor if your condition does not improve or worsens after 2-4 weeks of treatment.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to affected areas of the scalp once daily at bedtime. Rub in gently and thoroughly. Wash hair in the morning.
Condition-Specific Dosing:
scalpPsoriasis:
Apply once daily at bedtime to affected areas of the scalp. Leave on overnight (or for at least 4 hours), then wash hair in the morning. Treatment duration typically up to 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
For atopic dermatitis (6 months to 2 years): Apply a thin film to affected areas of the body and scalp once daily for up to 4 weeks. Do not use occlusive dressings.
Child:
For atopic dermatitis (2 years and older): Apply a thin film to affected areas of the body and scalp once daily for up to 4 weeks. For scalp psoriasis (2 years and older): Apply once daily at bedtime to affected areas of the scalp. Leave on overnight (or for at least 4 hours), then wash hair in the morning. Treatment duration typically up to 4 weeks.
Adolescent:
Same as adult dosing for scalp psoriasis. For atopic dermatitis, same as child dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Dialysis:
No specific considerations for topical use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its primary mechanism of action is thought to involve the induction of phospholipase A2 inhibitory proteins, lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Not well-defined for topical application; systemic absorption is minimal but can occur, especially with prolonged use, extensive surface area, occlusive dressings, or compromised skin barrier.
Tmax:
Not applicable for topical systemic effect; local effects are observed within hours to days.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable for topical use due to minimal systemic absorption.
ProteinBinding:
If absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration:
Limited to none with topical application.
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of absorbed corticosteroids varies.
Clearance:
Not applicable for topical use; systemic clearance occurs via hepatic metabolism and renal excretion.
ExcretionRoute:
Renal (primarily) and biliary (if absorbed systemically).
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Local anti-inflammatory and antipruritic effects typically within hours to days.
PeakEffect:
Clinical improvement usually observed within days to 1-2 weeks of consistent use.
DurationOfAction:
Effects persist as long as the medication is applied; duration of relief after cessation varies.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Irritation at the site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Irritation at the site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site
- Burning or stinging sensation that is severe or persistent
- Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area
- Development of new skin infections (e.g., pus, fever, spreading redness)
- Acne-like breakouts or increased hair growth in the treated area
- Signs of systemic absorption, especially in children: unusual weight gain, rounding of the face (moon face), slow growth, fatigue, muscle weakness.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you have a peanut allergy, be aware that some brands of this medication contain peanut oil. Before using, consult with your pharmacist to determine if your specific brand contains peanut oil.
This medication is not intended for treating diaper rash. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin. When applying to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Do not exceed the prescribed treatment duration. Your doctor will advise you on the appropriate length of use.
When administering this medication to children, use with caution, as the risk of certain side effects may be increased in this population. In some cases, this medication may affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
If you have a peanut allergy, be aware that some brands of this medication contain peanut oil. Before using, consult with your pharmacist to determine if your specific brand contains peanut oil.
This medication is not intended for treating diaper rash. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin. When applying to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Do not exceed the prescribed treatment duration. Your doctor will advise you on the appropriate length of use.
When administering this medication to children, use with caution, as the risk of certain side effects may be increased in this population. In some cases, this medication may affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar.
- Adrenal insufficiency may occur upon abrupt withdrawal after prolonged high-dose use.
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Treatment is symptomatic and supportive. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (severity of psoriasis/atopic dermatitis, presence of infection, skin integrity)
Rationale: To establish baseline for efficacy assessment and identify contraindications or precautions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in erythema, scaling, pruritus)
Frequency: Regularly during treatment, typically weekly or bi-weekly.
Target: Significant improvement or resolution of symptoms.
Action Threshold: Lack of improvement or worsening of symptoms after 2-4 weeks may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit.
Target: Absence or minimal signs of adverse reactions.
Action Threshold: Presence of significant or worsening local adverse reactions may require dose reduction, discontinuation, or change in therapy.
Signs of HPA axis suppression (e.g., fatigue, weight loss, nausea, dizziness) - especially in children or with extensive/prolonged use
Frequency: Periodically, particularly with prolonged use, large surface area application, or occlusive dressings.
Target: Normal adrenal function.
Action Threshold: Suspicion of HPA axis suppression warrants laboratory testing (e.g., ACTH stimulation test, plasma cortisol) and potential discontinuation or tapering of therapy.
Symptom Monitoring
- Increased redness or irritation at application site
- Burning or stinging sensation
- Thinning of the skin (atrophy)
- Stretch marks (striae)
- Spider veins (telangiectasias)
- Acne-like eruptions
- Folliculitis
- Signs of skin infection (pus, fever, spreading redness)
- Unusual fatigue or weakness
- Weight loss
- Nausea or vomiting
- Dizziness
Special Patient Groups
Pregnancy
Fluocinolone acetonide is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though systemic absorption from topical use is generally low.
Second Trimester:
Risk generally considered low with appropriate topical use.
Third Trimester:
Risk generally considered low with appropriate topical use. Avoid large areas or prolonged use.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when fluocinolone acetonide topical oil is administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, appropriate use. Monitor infant for signs of systemic corticosteroid effects (e.g., growth suppression) if mother uses extensively.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults because of a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Not recommended for use in children under 6 months of age. Monitor for growth retardation and delayed weight gain.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor skin integrity closely.
Clinical Information
Clinical Pearls
- Derma-Smoothe/FS Body Oil is a medium-potency topical corticosteroid. It is formulated as an oil, which can be beneficial for dry, scaly conditions like psoriasis.
- For scalp psoriasis, ensure the oil is applied to the scalp, not just the hair. Leave on for at least 4 hours or overnight for best results.
- For atopic dermatitis in infants, use for the shortest duration necessary (up to 4 weeks) and avoid occlusive dressings due to increased risk of systemic absorption.
- Patients should be educated on the signs of skin atrophy (thinning, bruising, striae) and HPA axis suppression, especially with prolonged or extensive use.
- Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the underlying skin condition.
- This formulation is specifically designed for the scalp and body; avoid use on the face, groin, or axillae unless specifically directed by a physician, due to higher risk of adverse effects in these sensitive areas.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone)
- Vitamin D analogs (e.g., calcipotriene for psoriasis)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for atopic dermatitis)
- Topical retinoids (e.g., tazarotene for psoriasis)
- Coal tar preparations
- Phototherapy
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine for severe cases)
Cost & Coverage
Average Cost:
Varies widely, typically $200 - $800+ per 120 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.