Derma-Smoothe/FS fluocinolone acetonide .11 mg/mL Oil, 1 bottle — NDC 68791-101-04 (Billing 68791-0101-04)
This is a package of 1 bottle of Derma-Smoothe/FS fluocinolone acetonide .11 mg/mL Oil from Royal Pharmaceuticals, LLC, marketed since Feb 1995 and currently FDA-listed; retail pharmacies pay about $0.2427 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68791-101-04 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68791 labeler · 101 product · 04 package
- Package marketed since
- Feb 16, 1995
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6879110104 8
- Medicaid fills, this package
- 68,380 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Fluocinolone Acetonide (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007507
- GCN: 85080
- GPI-14 (Medi-Span): 90550055101712
- HICL (First Databank): 002896
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1191307
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Creams, ointments and solutions calm itchy, inflamed skin. The oils treat atopic dermatitis or, for ear oil, chronic eczematous external otitis. Eye impl...
- Use the smallest amount that covers the area. Creams and ointments are usually a thin film a few times a day, and the oils follow their own schedule. If there's no improvement in 2...
- Tilt your head, gently pull your ear lobe back and up, and use the dropper to put in 5 drops. Stay tilted for about a minute, then pat away extra oil with a cotton ball. It's usual...
- Not the oil, unless your provider tells you to. Skin folds, armpits and groin carry a higher risk of side effects. Keep it out of your eyes, mouth and vagina.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.243 | $28.71 / 118.28 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.3262 | $38.58 / 118.28 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68791-0101-04 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE | $0.2427 / mL | $28.71 | 1995-02-16 | — | Active |
| 68791-0101-01 68791-101-01 | 1 BOTTLE in 1 CARTON / 20 mL in 1 BOTTLE | — | — | 2024-05-06 | — | Discontinued by firm |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Derma-Smoothe/FS fluocinolone acetonide .11 mg/mL Oil?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluocinolone acetonide .01 mg/100mL 45802-0485-26 | Padagis | 1 bottle | $0.171 | AT | Availability likely | save 29% |
| Fluocinolone Acetonide .11 mg/118.28mL 51672-1357-08 | Sun | 1 bottle | $0.171 | AT | Availability likely | save 29% |
| FLUOCINOLONE ACETONIDE Oil .11 mg/mL 64980-0330-04 | RISING | 118.28 ml | $0.171 | AT | Availability likely | save 29% |
| Fluocinolone Acetonide .11 mg/mL 70752-0158-06 | Quagen | 1 bottle | $0.171 | AT | Availability likely | save 29% |
| fluocinolone acetonide .01 mg/100mL 45802-0887-26 | Padagis | 1 bottle | $0.175 | AT | Availability likely | save 28% |
| Fluocinolone Acetonide .11 mg/118.28mL 51672-1356-08 | Sun | 1 bottle | $0.175 | AT | Availability likely | save 28% |
| Fluocinolone Acetonide Oil .11 mg/mL 64980-0331-04 | Rising | 118.28 ml | $0.175 | AT | Availability likely | save 28% |
| Fluocinolone Acetonide .11 mg/mL 70752-0156-06 | Quagen | 1 bottle | $0.175 | AT | Availability likely | save 28% |
| Fluocinolone Acetonide .11 mg/118.28mL 65162-0703-86 | Amneal | 1 bottle | $0.222 | — | Discontinued | save 9% |
| Fluocinolone Acetonide .11 mg/mL 68462-0590-89 | Glenmark | 1 bottle | $0.222 | — | FDA listed | save 9% |
| Derma-Smoothe/Fs .11 mg/mL 68791-0102-04 | Royal | 1 bottle | $0.242 | AT | Availability likely | +0% |
| Derma-Smoothe/FS .11 mg/mLthis 68791-0101-04 | Royal | 1 bottle | $0.243 | AT | Availability likely | — |
| Fluocinolone Acetonide Oil .11 mg/mL 50090-6780-00 | A-S | 118.28 ml | — | AT | FDA listed | — |
| Fluocinolone acetonide .01 mg/100mL 50090-7958-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| fluocinolone acetonide .01 mg/100mL 63629-8655-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone acetonide .01 mg/100mL 63629-8656-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone Acetonide .11 mg/mL 71335-2883-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone Acetonide .11 mg/mL 71335-2884-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone acetonide .01 mg/100mL 72162-1412-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
| fluocinolone acetonide .01 mg/100mL 72162-1434-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone Acetonide .11 mg/mL 72162-2319-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinolone Acetonide .11 mg/mL 72162-2321-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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UNII 7L6R1SQ6M0
Oleth-2 is a synthetic chemical made by combining ethylene oxide with oleyl alcohol. It works as an emulsifier and surfactant, helping mix oil and water-based ingredients together in medicines and allowing better absorption through the skin.
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UNII 5TL50QU0W4
Peanut oil is a plant-based oil extracted from peanuts. It's used in medicines as a solvent and carrier to dissolve or suspend active ingredients, making them easier to deliver and absorb in the body.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Royal Pharmaceuticals, LLC labeler code 68791
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE DERMA-SMOOTHE/FS Body Oil is a corticosteroid indicated for the topical treatment of: • atopic dermatitis in adults (1) • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older (1) Derma-Smoothe/FS ® Body Oil is indicated for the topical treatment of: • atopic dermatitis in adults • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • DERMA-SMOOTHE/FS Body Oil is not for oral, ophthalmic, or intravaginal use. ( 2.1 ) • Do not use on face or intertriginous areas. ( 2.1 ) • Adult patients: Apply to affected areas 3 times daily. ( 2.2 ) • Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.3 )
2.1Important Administration Instructions DERMA-SMOOTHE/FS Body Oil is for topical use only. Not for oral, ophthalmic, or intravaginal use. Apply the least amount of DERMA-SMOOTHE/FS Body Oil needed to cover the affected areas.
Discontinue use when control of disease is achieved within 2 weeks or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use on the face, axillae, or groin unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] .
Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use [see Warnings and Precautions (5.1)] .
2.2Recommended Dosage in Adults Apply DERMA-SMOOTHE/FS Body Oil as a thin film to the affected areas three times daily.
2.3Recommended Dosage in Pediatric Patients Moisten skin and apply DERMA-SMOOTHE/FS Body Oil as a thin film to the affected areas twice daily for up to four weeks.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS DERMA-SMOOTHE/FS Body Oil is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces. DERMA-SMOOTHE/FS Body Oil is a topical oil containing 0.01% fluocinolone acetonide supplied in bottles containing 4 fluid ounces. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) o Pediatric patients may be more susceptible to systemic toxicity from equivalent doses. ( 5.1 , 8.4 ) o Systemic absorption may require evaluation for HPA axis suppression.
Potent corticosteroids use on large areas, prolonged use, occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption. Modify use should HPA axis suppression develop. ( 5.1 ) Local Adverse Reactions: Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids ( 5.2 , 6.1 ) Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract.
Avoid contact of DERMA-SMOOTHE/FS Body Oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ( 5.3 )
5.1Endocrine System Adverse Reactions Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing’s syndrome, hyperglycemia, and glucosuria can result from systemic absorption of topical corticosteroids. HPA axis suppression and Cushing’s syndrome have been reported in pediatric patients receiving topical corticosteroids.
Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ] . Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, reduce the frequency of application or discontinue DERMA-SMOOTHE/FS Body Oil, or substitute with a less potent corticosteroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
5.2Local Adverse Reactions Local adverse reactions may occur with use of topical corticosteroids, including DERMA-SMOOTHE/FS Body Oil, and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria [see Adverse Reactions (6.1) ] .
5.3Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of DERMA-SMOOTHE/FS Body Oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
5.4Allergic Contact Dermatitis Use of topical corticosteroids can cause allergic contact dermatitis. Allergi… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).
( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals, Inc. at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. An open-label trial was conducted in 58 pediatric subjects 2 years to 12 years of age with moderate to severe atopic dermatitis to evaluate the safety of DERMA-SMOOTHE/FS Body Oil when applied to the face twice daily for 4 weeks.
Adverse reactions reported by ≥2% of pediatric subjects treated with DERMA-SMOOTHE/FS Body Oil are shown in Table 1. Table 1: Adverse Reactions in ≥ 2% of Pediatric Subjects 2 Years to 12 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with DERMA-SMOOTHE/FS Body Oil, N=58 Adverse Reaction (AR) The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reports of an adverse reaction. n (%) Day 14 Day 28 End of Treatment Day 56 Four Weeks Post Treatment Any AE 15 (26) 6 (10) 7 (12) 7 (12) Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4) Erythema 3 (5) 3 (5) Itching 3 (5) 3 (5) Irritation 3 (5) 3 (5) Burning 3 (5) 3 (5) Hypopigmentation 2 (4) 2 (4) Shiny skin 1 (2) 1 (2) Secondary atopic dermatitis 1 (2) 1 (2) Papules and pustules 1 (2) 1 (2) Keratosis pilaris 1 (2) 1 (2) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2) An open-label safety trial was conducted in 29 pediatric subjects 3 months to 2 years of age to assess the HPA axis by ACTH stimulation testing following use of DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks.
The trial included 7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area (BSA). Eleven (11) subjects had baseline BSA involvement of 50% to 75% and 7 subjects had BSA involvement of greater than 75% [see Use in Specific Populations (8.4) ] .
The most common adverse reactions reported in the study (≥2%) are shown in Table 2. Table 2: Adverse Reactions in ≥2% of Pediatric Subjects 3 Months to 2 Years of Age with Moderate to Severe Atopic Dermatitis, Treated with DERMA-SMOOTHE/FS Body Oil, N=30 Includes one subject who withdrew at Week 2 Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3)
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Endocrine Disorders: HPA axis suppression and Cushing’s syndrome [see Use in Specific Populations (8.4) ] • Eye Disorders: glaucoma and cataracts [see Warnings and Precautions (5.3) ] • Nervous System Disorders: intr… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible.
Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary There is no information regarding the presence of fluocinolone acetonide in breast milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible while breastfeeding.
Advise breastfeeding women not to apply DERMA-SMOOTHE/FS Body Oil directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DERMA-SMOOTHE/FS Body Oil and any potential adverse effects on the breastfed infant from DERMA-SMOOTHE/FS Body Oil or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of DERMA-SMOOTHE/FS Body Oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks. Safety and effectiveness of DERMA-SMOOTHE/FS Body Oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions (5.1) ] .
Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of DERMA-SMOOTHE/FS Body Oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls).
The trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, DERMA-SMOOTHE/FS Body Oil and histamine/saline controls. Subjects were also treated with DERMA-SMOOTHE/FS Body Oil twice daily for 7 days. Prick test and patch test results for… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible.
Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of DERMA-SMOOTHE/FS Body Oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks. Safety and effectiveness of DERMA-SMOOTHE/FS Body Oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions (5.1) ] .
Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of DERMA-SMOOTHE/FS Body Oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls).
The trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, DERMA-SMOOTHE/FS Body Oil and histamine/saline controls. Subjects were also treated with DERMA-SMOOTHE/FS Body Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to DERMA-SMOOTHE/FS Body Oil and the refined peanut oil.
One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of DERMA-SMOOTHE/FS Body Oil. Evaluation in Pediatric Patients 2 to 6 years old Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 2 to 6 years old is supported by open-label safety trials conducted in 33 pediatric subjects (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects.
Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2) ] .
Evaluation in Pediatric Patients 3 months to 2 years old Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 3 months to 2 years old is supported by an open-label safety trial conducted in 29 pediatric subjects (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) to assess the HPA axis by ACTH stimulation testing following use of DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks [see Adverse Reactions (6.1) ] . Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment.
All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.
12.2Pharmacodynamics Vasoconstrictor Assay DERMA-SMOOTHE/FS Body Oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression was evaluated in 29 pediatric subjects 3 months to 2 years old (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) and 33 pediatric subjects 2 years to 12 years old (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe atopic dermatitis.
Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. In subjects 3 months to 2 years old, all subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).
In subjects 2 to 12 years old, 4 out of 18 subjects 2 to 5 years old showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) at the end of treatment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] .
12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption.
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in atopic dermatitis is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED / STORAGE AND HANDLING DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide) topical oil, 0.01% (NDC # 68791-101-04) is supplied in bottles containing 4 fluid ounces. Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide), topical oil, 0.01% contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50.
It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of DERMA-SMOOTHE/FS Body Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil and fragrances. DERMA-SMOOTHE/FS Body Oil is formulated with 48% refined peanut oil.
The bulk refined peanut oil, used in DERMA-SMOOTHE/FS Body Oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in DERMA-SMOOTHE/FS Body Oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm). Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions Advise patients that DERMA-SMOOTHE/FS Body Oil is for topical use only [see Dosage and Administration (2.1) ] . Advise patients to not to apply DERMA-SMOOTHE/FS Body Oil under occlusion unless directed by their healthcare provider. Instruct patients not to apply DERMA-SMOOTHE/FS to the diaper area as diapers or plastic pants may constitute occlusive use [see Dosage and Administration (2.1) ] .
Advise patients to avoid use of DERMA-SMOOTHE/FS Body Oil on the face, axillae, or groin unless directed by their healthcare provider [see Dosage and Administration (2.1) ] . Advise patients to discontinue therapy when control of disease is achieved. Instruct patients to contact their healthcare provider if no improvement is seen within 2 weeks [see Dosage and Administration (2.1) ] .
Endocrine System Adverse Reactions Instruct patients not to use other corticosteroid-containing products while using DERMA-SMOOTHE/FS Body Oil without first consulting their healthcare provider [see Warnings and Precautions (5.1) ] . Ophthalmic Adverse Reactions Advise patients to avoid contact with the eyes and in case of contact, wash eyes liberally with water. Instruct patients to tell their healthcare provider if they develop any visual symptoms [see Warnings and Precautions (5.3) ].
Pregnancy and Lactation Advise patients to use DERMA-SMOOTHE/FS Body Oil on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise patients that are breastfeeding not to apply DERMA-SMOOTHE/FS Body Oil directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.1 and 8.2) ] .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption.
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Vasoconstrictor Assay DERMA-SMOOTHE/FS Body Oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression HPA axis suppression was evaluated in 29 pediatric subjects 3 months to 2 years old (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) and 33 pediatric subjects 2 years to 12 years old (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe atopic dermatitis.
Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. In subjects 3 months to 2 years old, all subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL).
In subjects 2 to 12 years old, 4 out of 18 subjects 2 to 5 years old showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) at the end of treatment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] .
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, mutagenesis, impairment of fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with DERMA-SMOOTHE/FS Body Oil. However, some corticosteroids are 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).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, mutagenesis, impairment of fertility No carcinogenicity, genotoxicity, or fertility studies were conducted with DERMA-SMOOTHE/FS Body Oil. However, some corticosteroids are 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).
📄 Package Label / Principal Display Panel ▾
Principal Display Panel PRINCIPAL DISPLAY PANEL - 118.28 mL Carton Label NDC 68791-101-04 Rx only Derma-Smoothe/FS ® Fluocinolone Acetonide 0.01% Topical Oil (BODY OIL) FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC, or INTRAVAGINAL USE SHAKE WELL BEFORE USE Net Contents 118.28 mL (4 fL. oz.) ROYAL PHARMACEUTICALS ® 118.28 mL Carton Label