Derma-Smoothe / FS

This section provides information on the proper use of a number of products that contain fluocinolone. It may not be specific to Derma-Smoothe/FS. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, ointment, solution, and body oil:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use shampoo:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Shake the container well, and apply about an ounce of the shampoo to the scalp area.
• Work the shampoo into a lather, and leave on the scalp for 5 minutes.
• Wash hair and scalp thoroughly with water.

To use scalp oil:

• Wash your hands with soap and water before and after using this medicine.
• Wet hair and scalp thoroughly.
• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
• Cover the scalp with the supplied shower cap overnight for at least 4 hours.
• Wash hair with regular shampoo and clean well.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:
  • For topical dosage form (cream, ointment, and solution):
    • Adults—Apply to the affected areas of the skin three to four times a day.
    • Children—Use and dose must be determined by your doctor.
  • For topical dosage form (body oil):
    • Adults—Apply to the affected areas of the skin three times a day for up to 2 weeks.
    • Children 3 months of age and older—Apply to the affected areas two times a day for up to 4 weeks.

• For seborrheic dermatitis:
  • For topical dosage form (shampoo):
    • Adults—Use on the scalp area once a day.
    • Children—Use and dose must be determined by your doctor.

• For scalp psoriasis:
  • For topical dosage form (scalp oil):
    • Adults—Apply to the affected areas of the scalp and leave overnight.
    • Children 2 years of age and older—Apply to the affected areas 2 times a day for up to 4 weeks.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Derma-Smoothe/FS® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF (see PRECAUTIONS section).

General:

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS-Pediatric use)

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic testing. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS® (see CLINICAL STUDIES section).

If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, Derma-Smoothe/FS® should be discontinued immediately and appropriate therapy instituted.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Derma-Smoothe/ FS® should be discontinued until the infection has been adequately controlled.

Derma-Smoothe/FS® is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm). Physicians should use caution in prescribing Derma-Smoothe/FS® for peanut sensitive individuals.

Information for Patients:

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. In case of contact, wash eyes liberally with water.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. Patients should promptly report to their physician any worsening of their skin condition.
4. Parents of pediatric patients should be advised not to use Derma-Smoothe/FS® in the treatment of diaper dermatitis. Derma-Smoothe/FS® should not be applied to the diaper area as diapers or plastic pants may constitute occlusive dressing.
5. This medication should not be used on the face, underarm, or groin unless directed by the physician.
6. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests:

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment of fertility:

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Derma-Smoothe/FS®. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in Derma-Smoothe/FS®. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).

Pregnancy:

Teratogenic effects: Pregnancy category C.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from Derma-Smoothe/FS®. Therefore, Derma-Smoothe/FS® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Derma-Smoothe/FS® is administered to a nursing woman.

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS®.

A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of Derma-Smoothe/FS® when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events).

Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 68791-102-04).

Scalp Oil is supplied with 2 shower caps.

Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature].

CAUTION: Rx only

Manufactured by:
Hill Dermaceuticals, Inc.®
Sanford, FL 32773
1.800.344.5707

For: Royal Pharmaceuticals, Inc
Manasquan, NJ 08736
1.800.510.3401

Rev. CODE 171A239
Date: 6/2013

Applies to fluocinolone topical: topical application cream, topical application gel/jelly, topical application kit, topical application lotion, topical application oil, topical application ointment, topical application shampoo, topical application solution

Along with its needed effects, fluocinolone topical (the active ingredient contained in Derma-Smoothe / FS) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluocinolone topical:

• Body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• headache
• hoarseness
• lightening of normal skin color
• lightening of treated areas of dark skin
• sore throat
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

• Acne or pimples
• accumulation of pus
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• burning and itching of the skin with pinhead-sized red blisters
• change in hearing
• cracked, dry, scaly skin
• diarrhea
• dry skin
• earache or pain in the ear
• ear drainage
• flushing or redness of the skin
• darkening of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body
• ooze thick white fluid
• raised, dark red, wart-like spots on skin, especially when used on the face
• redness or swelling in the ear
• skin irritation
• skin rash, encrusted, scaly and oozing
• spots on your skin resembling a blister or pimple
• swelling
• swollen, red, tender area of infection
• thickened patches of the skin
• vomiting

• Redness and scaling around the mouth
• thinning, weakness, or wasting away of the skin

Some side effects of fluocinolone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Changes in skin color
• shiny skin

• increased hair growth on the forehead, back, arms, and legs
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Applies to fluocinolone topical: compounding powder, topical cream, topical kit, topical lotion, topical oil, topical ointment, topical shampoo, topical solution

General

The most commonly reported side effects were erythema, itching, irritation, and burning.[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Immunologic

Common (1% to 10%): Facial herpes simplex, abscess, molluscum[Ref]

Local

Common (1% to 10%): Telangiectasia, erythema, itching, irritation, burning, hypopigmentation, hyperpigmentation, shiny skin, folliculitis, acneiform eruptions[Ref]

Nervous system

Frequency not reported: Intracranial hypertension (including bulging fontanelles, headaches, bilateral papilledema)

Dermatologic

Common (1% to 10%): Secondary atopic dermatitis, papules and pustules, keratosis pilaris, eczema, rash
Frequency not reported: Hypertrichosis, maceration of the skin, dermatitis, perioral dermatitis, acne or worsening of acne, acne rosacea[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Some side effects of Derma-Smoothe / FS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.