Fluocinolone Acetonide
Derma-Smoothe/FS
Derma-Smoothe/FS is an FDA-approved topical medication containing Fluocinolone Acetonide. It relieves redness, itching, swelling, or discomfort caused by atopic dermatitis (eczema) and scalp psoriasis. It is available in scalp oil or body oil in strength 0.01%. The dosage varies based on severity and is typically applied once or twice daily. It is suitable for adults and children (4 weeks- 3 months older). You should avoid contact with eyes and mucous membranes to prevent irritation. Common side effects generally include skin irritation or dryness. If a dose is missed, apply it promptly unless close to the next scheduled dose. Store Derma Smoothe oil at room temperature, away from dampness and heat, and place it out of reach for children. You can follow your healthcare provider’s guidance for safe usage.
Product Overview
Derma-Smoothe/FS is an FDA-approved topical medication for treating redness, itching, swelling, or other discomfort caused by atopic dermatitis (a form of eczema) and scalp psoriasis. Its active ingredient is Fluocinolone Acetonide, a potent corticosteroid known for its anti-inflammatory properties. Fluocinolone Acetonide works by reducing inflammation, suppressing the immune response in the affected area, and alleviating symptoms associated with these skin conditions.
It is typically available as Derma Smoothe scalp or body oil in strength 0.01% Fluocinolone Acetonide. The dosage and application method may vary based on the stringency of the condition and the individual’s response to treatment. It is usually applied to the affected skin area 1-3 times daily, as directed by a healthcare professional. It is suitable for adults and children (4 weeks to 3 months). The dosage may need to be adjusted accordingly for pediatric patients.
Common side effects generally include skin irritation, burning, itching, or dryness at the application site. Precautions should be taken to avoid contact with the eyes and mucous membranes, as this may cause irritation or other complications. In case of a missed dose, applying the medication as soon as possible is recommended unless it is almost time for the next scheduled dose. It should be kept at room temperature, distant from moisture and heat, and out of reach by children. It is important to follow all guidance the healthcare provider provides to ensure the safe and effective use of Derma Smoothe oil.
Uses of Derma-Smoothe/FS
It is used for the treatment of:
- Scalp psoriasis for adults and children (over 2 years old).
- Moderate to serious atopic dermatitis for adults and children (over 3 months old).
[Important warning: Derma Smoothe oil is for topical use only, not for oral, ophthalmic, or vaginal use.]
How to Use Derma-Smoothe/FS?
Dosage
Strengths and Forms
Form 1: Derma-Smoothe Body Oil
Strength: 0.01% Fluocinolone Acetonide
Form 2: Derma-Smoothe Scalp Oil
Strength: 0.01% Fluocinolone Acetonide
Recommended Dosage for Derma-Smoothe/FS
For Adults with Eczema:
- Apply a thin layer of Derma-Smoothe/FS body oil to the affected area(s) thrice daily.
For Children (Over 3 Months Old) with Eczema:
- Moisten the skin and apply a thin layer of Derma-Smoothe/FS body oil to the affected area(s) twice daily for up to 4 weeks.
For Adults with Scalp Psoriasis:
- Wet hair and scalp properly, apply a thin layer of Derma-Smoothe/FS scalp oil, and massage into the scalp.
- Cover with a shower cap and leave on overnight or for at least 4 hours, then wash off with regular shampoo.
For Children (Over 2 Years Old) with Scalp Psoriasis:
- Wet hair and scalp properly, apply a thin layer of Derma-Smoothe/FS scalp oil, and massage into the scalp.
- Cover with a shower cap and leave on overnight or for at least 4 hours, then wash off with regular shampoo.
- Use Derma-Smoothe/FS scalp oil on the scalp for no longer than 4 weeks at a time.
[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your Derma-Smoothe/FS dosage accordingly.]
How to Take It?
Here is a step-by-step guideline to use Derma Smoothe oil:
Step 1. Cleanse the affected area of the skin gently with mild soap and water. Pat the site dry using a clean towel.
Step 2. Before use, shake the Derma Smoothe oil bottle to ensure the medication is properly mixed.
Step 3.
- Use your fingers or a cotton swab to apply a thin layer of Derma Smoothe oil to the affected skin area for body application.
- For scalp application, part the hair and apply directly onto the affected skin of the scalp using the applicator tip provided for your fingers.
Step 4. After applying the oil, gently massage it into the skin or scalp until absorbed. Do not rub vigorously, as this may irritate the skin or scalp further.
Step 5. After application, please wash your hands properly to remove any medication that may have come into contact with them.
Step 6. Avoid getting Derma Smoothe oil in your eyes or on mucous membranes, especially inside your nose or mouth. If accidental contact occurs, rinse the area thoroughly with water.
[Note: Your doctor will decide the right amount of Derma-Smoothe/FS for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]
How Does Derma-Smoothe/FS Work?
Derma-Smoothe/FS contains Fluocinolone Acetonide, a corticosteroid that decreases inflammation, itching, and redness associated with various skin conditions like psoriasis and eczema. When applied topically, Fluocinolone Acetonide penetrates the skin and binds to glucocorticoid receptors, leading to the inhibition of inflammatory mediators and the suppression of immune responses. This action helps to alleviate symptoms and promote the healing of affected skin areas, providing relief from discomfort and improving the skin’s overall condition.
Important Safety Information
Side Effects
Common side effects of Derma-Smoothe/FS may include:
- Skin irritation at the site of application
- Burning or stinging sensation
- Itching
- Dryness or peeling of the skin
Mild side effects of Derma-Smoothe/FS may include:
- Temporary alterations in skin color (lightening or darkening)
- Thinning of the skin
- Acne or pimples
- Excessive hair growth
- Stretch marks
Adverse side effects of Derma-Smoothe/FS may include:
- Allergic reactions such as redness, irritation, or inflammation of the face, tongue, or throat
- Severe skin irritation or redness
- Skin infection or increased risk of infections
- Vision changes if the medication comes into contact with the eyes
- Signs of Cushing’s syndrome (such as weight gain, moon face, or increased thirst)
[Note: This list may not cover all possible Derma-Smoothe/FS side effects. Always consult with your healthcare giver for medical advice about side effects.]
Warnings
- Topical Steroid Withdrawal: Prolonged use of Derma-Smoothe/FS, especially on large areas of the body or under occlusive dressings, may lead to topical steroid withdrawal syndrome upon discontinuation. Symptoms of withdrawal may include redness, burning, itching, and worsening of the skin condition. Gradual tapering of the oil under medical supervision is necessary to diminish the risk of withdrawal symptoms.
- Systemic Effects: Topical corticosteroids, including Fluocinolone Acetonide in Derma-Smoothe/FS, can be absorbed through the skin sufficiently to produce systemic effects. This is more likely to occur with prolonged use, application to large areas of the body, or under occlusive dressings. Systemic effects may include adrenal suppression, Cushing’s syndrome, hyperglycemia, and glycosuria. Monitoring for systemic effects is important, especially in vulnerable populations such as children, pregnant women, and patients with certain medical conditions.
- Skin Atrophy: Prolonged or excessive use of Derma-Smoothe/FS may lead to skin atrophy, characterized by skin thinning, telangiectasia, and striae. Avoid prolonged use or application to large body areas to minimize the risk of skin atrophy. If skin atrophy occurs, discontinue use and consult a healthcare provider.
- Hypersensitivity Reactions: Allergic reactions, including contact dermatitis, may occur using Derma-Smoothe/FS. Discontinue using the oil and consult a healthcare provider if signs of an allergic reaction, such as redness, itching, or swelling, develop.
- Ophthalmic Effects: Avoid contact of Derma-Smoothe/FS with the eyes, as it may cause irritation or exacerbate ocular conditions. In case of accidental exposure to the eyes, rinse thoroughly with water and seek medical attention if irritation persists.
- Infections: Topical corticosteroids may mask the symptoms of bacterial, fungal, or viral infections, leading to delayed diagnosis and treatment. Use caution in preexisting skin infections and monitor for signs of infection during treatment. If infection develops, discontinue Derma-Smoothe/FS and initiate appropriate therapy.
- Pediatric Use: The safety and efficacy of Derma-Smoothe/FS in pediatric patients have not been established for prolonged use. Use in pediatric patients should be limited to the smallest effective amount and shortest duration possible to minimize the risk of systemic effects and growth suppression.
- Use During Pregnancy and Lactation: Use of Derma-Smoothe/FS during pregnancy or lactation may pose risks to the fetus or nursing infant. Use only if the possible benefits outweigh the risks to the mother and fetus. Exercise caution and discuss with a healthcare provider before using Derma-Smoothe/FS during pregnancy or breastfeeding.
Precautions
- Avoid Excessive Use: You should use Derma-Smoothe/FS only as directed by your healthcare provider. Avoid using larger amounts or applying it more often than recommended, as this can increase the risk of systemic side effects and skin reactions.
- Limit Duration of Use: You should use Derma-Smoothe/FS for the shortest duration necessary to control your symptoms. Prolonged use may lead to skin thinning, increased risk of systemic effects, and other adverse reactions.
- Avoid Occlusive Dressings: Unless your healthcare provider recommends, avoid covering the treated area with occlusive dressings such as plastic wrap or tight clothing. Occlusive dressings can increase the absorption of the medication and may lead to systemic effects.
- Use with Caution on Sensitive Areas: Take extra care when applying Derma-Smoothe/FS to sensitive areas of the body, such as the face, groin, and armpits. These areas may be more prone to skin thinning and other adverse reactions.
- Monitor for Adverse Reactions: Keep an eye out for any signs of skin irritation, allergic reactions, or systemic effects while using Derma-Smoothe/FS. If you experience redness, itching, burning, or other such signs, discontinue use and consult your healthcare provider.
- Avoid Getting It in Your Eyes and Mucous Membranes: Be careful to avoid getting Derma-Smoothe/FS in your eyes, mouth, or nose. If accidental contact occurs, rinse the affected area with water immediately and seek medical advice if irritation persists.
- Inform Your Healthcare Provider: Make sure to tell your healthcare professional about any other drugs you are taking, including over-the-counter drugs and supplements. Some medications may interact with Derma-Smoothe/FS, potentially increasing the chances of side effects or reducing its effectiveness.
- Keep Out of Reach of Children and Pets: Reserve Derma-Smoothe/FS away from children and pets. Accidental intake or misuse of the oil by children can lead to serious adverse effects.
- Follow Usage Instructions Carefully: Adhere to the dosage and application guidelines given by your healthcare provider or as indicated on the medication label. Using Derma-Smoothe/FS correctly helps to ensure its effectiveness and diminish the risk of side effects.
Derma-Smoothe/FS Contraindications
- Hypersensitivity to Fluocinolone Acetonide or any component of the formulation.
- Use on infected or open wounds without appropriate antimicrobial therapy.
- Avoid use on the face, groin, or axillae unless directed by a healthcare provider.
- In patients with rosacea, acne vulgaris, or perioral dermatitis.
- Not recommended for use in children under 2 years of age.
Missed Dose
- Apply the missed Derma-Smoothe/FS dose as soon as it is remembered.
- If close to the next scheduled dose, skip the missed dose.
- Avoid applying extra medication to compensate.
[Note: If you have missed a dose of your Derma Smoothe oil and are still determining when to take the next one, immediately consult your doctor or pharmacist.]
Overdose
Symptoms of an overdose may include skin thinning, stretch marks, or increased hair growth.
Avoid accidental ingestion or overapplication.
[Note: If you consumed more than the recommended Derma-Smoothe/FS dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]
Storage
- Store it at room temperature, distant from light and moisture.
- Keep the oil tightly closed in its original container.
- Avoid storing in the bathroom or near heat sources.
- Keep children and pets away to prevent accidental ingestion.
- Do not freeze Derma-Smoothe/FS.
- Inspect the expiration date and dispose of any expired oil appropriately.
[Note: Discuss with your healthcare professional about the proper disposal of any unused Derma-Smoothe/FS and any questions you may have regarding its storage.]
Derma-Smoothe/FS Interactions
- Acetaminophen
- Actifed Cold and Allergy (chlorpheniramine/phenylephrine)
- Advil (ibuprofen)
- Advil Cold and Sinus (ibuprofen / pseudoephedrine)
- Alendronate
- Alpha-lipoic acid
- Apidra SoloStar (insulin glulisine)
- Aquaphor (emollients topical)
- Arthritis Pain Relief (acetaminophen)
- Baclofen
- Benzaclin (benzoyl peroxide/clindamycin topical)
- Clobetasol topical
- Crestor (rosuvastatin)
- Folic acid
- Humira (adalimumab)
- Iron Sulfate (ferrous sulfate)
- Levothyroxine
- Lisinopril
- Loratadine
- Methotrexate
- Otezla (apremilast)
- Pantoprazole
- Potassium chloride
- Promethazine
- Protopic (tacrolimus topical)
- Tamsulosin
- Tretinoin topical
- Vitamin D3 (cholecalciferol)
- Voltaren Arthritis Pain Gel (diclofenac topical)
- Warfarin
Disease Interactions:
- Diabetes
- Diaper rash
- Hyperadrenocorticism
- Infections
- Ocular toxicities
[Note: This isn’t a complete list, and there could be other drugs that interact with Derma-Smoothe/FS. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]
Derma-Smoothe/FS Alternatives
- Capex (fluocinolone acetonide)
- Dermotic (fluocinolone acetonide)
- Fluonid (fluocinolone acetonide)
- Flurosyn (fluocinolone acetonide)
- FS Shampoo (fluocinolone acetonide)
- Synalar Cream (fluocinolone acetonide)
[Note: Your doctor will choose the best alternative to Derma-Smoothe/FS for you. Only use these alternative medications after consulting your healthcare provider. Taking them by yourself may cause serious side effects.]
Frequently Asked Questions
Is Derma-Smoothe/FS a steroid?
Derma-Smoothe/FS is a topical body oil used to treat atopic dermatitis (a type of eczema) and scalp psoriasis. It contains fluocinolone, which is a steroid. This medication reduces inflammation by affecting the actions of certain chemicals in the body.
How long does it take for Derma Smoothe oil to work?
While individual responses for Derma Smoothe oil may vary, you should see some improvements within 2 weeks of use. The full effects may take up to 4 weeks to become noticeable. Remember to use it for the minimum time necessary to heal the skin condition, and if no improvement is seen within 2 weeks, consult your doctor.
Can I use Derma Smoothe oil on my face?
Derma Smoothe oil is primarily intended to treat atopic dermatitis (eczema) and scalp psoriasis. However, it is not recommended for use on the face. Facial skin is more sensitive, and prolonged use of corticosteroids can result in adverse effects such as thinning of the skin, redness, and increased blood vessels. If you have any concerns about using this medication on your face, consult your healthcare provider for personalized advice.
How often do I use Derma-Smoothe/FS scalp oil?
Derma Smoothe Scalp oil should be used twice a day on the affected areas of the scalp. Apply a very light layer and massage it gently. Remember to follow your doctor’s instructions carefully and discontinue use once the condition improves. If you have any concerns or experience side effects, consult your healthcare provider.
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