Version May 2024
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time. Therapy should be discontinued when control is achieved.
Atopic dermatitis: Topical: Body oil: Apply thin film to affected area 3 times daily
Corticosteroid-responsive dermatoses: Topical: Cream, ointment, solution: Apply a thin layer to affected area 2 to 4 times daily; may use occlusive dressings to manage psoriasis or recalcitrant conditions
Scalp psoriasis: Topical: Scalp oil: Apply a thin film onto scalp and massage thoroughly into wet or dampened hair/scalp; cover with shower cap. Leave on overnight (or for at least 4 hours). Remove by washing hair with shampoo and rinsing thoroughly.
Seborrheic dermatitis of the scalp: Topical: Shampoo: Apply no more than 1 ounce to scalp once daily; work into lather and allow to remain on scalp for ~5 minutes. Remove from hair and scalp by rinsing thoroughly with water.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Fluocinolone (topical): Pediatric drug information")
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time to avoid HPA axis suppression. Therapy should be discontinued when control is achieved.
Atopic dermatitis, moderate to severe:
Derma-Smoothe/FS body oil (0.01%): Infants ≥3 months, Children, and Adolescents: Topical: Moisten skin; apply a thin film to affected area twice daily; do not use for longer than 4 weeks
Derma-Smoothe/FS scalp oil (0.01%): Limited data available: Children ≥2 years and Adolescents: Topical: Apply a thin film to affected area twice daily; do not use longer than 4 weeks
Corticosteroid-responsive dermatoses: Synalar cream (0.025%), ointment (0.025%), topical solution (0.01%): Children and Adolescents: Topical: Apply thin layer 2 to 4 times daily to affected area; may use occlusive dressings to manage psoriasis or recalcitrant conditions
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for body or scalp oil in infants and children.
Frequency not defined:
Dermatologic: Acneiform eruptions, atopic dermatitis (secondary), burning sensation of skin, eczema, erythema of skin, folliculitis, hyperkeratosis (keratosis pilaris), hyperpigmentation, hypopigmentation, molluscum contagiosum, papule of skin, pruritus, scalp pustules, skin irritation, skin rash, taut and shiny skin, telangiectasia
Gastrointestinal: Diarrhea, vomiting
Infection: Abscess, herpes simplex infection (facial)
Otic: Otic infection
Respiratory: Cough, nasopharyngitis, rhinorrhea, upper respiratory tract infection
Miscellaneous: Fever
Hypersensitivity to fluocinolone or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Viral (eg, herpes, varicella) lesions of the skin; bacterial or fungal skin infections; parasitic infections; skin manifestations relating to tuberculosis or syphilis; eruptions following vaccinations; application to the eye
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
• Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection miliaria); may be irreversible. Local adverse reactions are more likely to occur with occlusive and/or prolonged use. If irritation develops, discontinued use and institute appropriate therapy.
• Skin infections: Concomitant skin infections may be present or develop during therapy; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Peanut oil: Derma-Smoothe/FS products may contain peanut oil; use caution in peanut-sensitive individuals.
Other warnings/precautions:
• Appropriate use: Not for oral, ophthalmic, or intravaginal use; do not apply to the face, axillae, groin, or diaper area unless directed by health care provider. Use the least amount needed to cover the affected area; discontinue when control is achieved. If improvement is not seen within 2 weeks, reassess.
• Appropriate use: Shampoo: Has not been proven to be effective in corticosteroid responsive dermatoses other than seborrheic dermatitis of the scalp.
Topical corticosteroids may be absorbed percutaneously. The extent of absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, prolonged duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Hypothalamic-pituitary-adrenal (HPA) suppression may occur, particularly in younger children or in patients receiving high doses for prolonged periods; acute adrenal insufficiency (adrenal crisis) may occur with abrupt withdrawal after long-term therapy or with stress. Infants and small children may be more susceptible to HPA axis suppression or other systemic toxicities due to larger skin surface area to body mass ratio; use with caution in pediatric patients.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP, 1997; Shehab, 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as acetonide:
Synalar: 0.025% (120 g) [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Generic: 0.01% (15 g, 60 g); 0.025% (15 g, 60 g)
Kit, External, as acetonide:
Synalar (Cream): 0.025% [DSC] [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Synalar (Ointment): 0.025% [DSC]
Synalar TS: 0.01% [DSC] [contains propylene glycol]
Oil, External, as acetonide:
Derma-Smoothe/FS Body: 0.01% (118.28 mL) [contains isopropyl alcohol, peanut oil]
Derma-Smoothe/FS Scalp: 0.01% (20 mL [DSC], 118.28 mL) [contains isopropyl alcohol, peanut oil]
Generic: 0.01% (118.28 mL)
Ointment, External, as acetonide:
Synalar: 0.025% (120 g)
Generic: 0.025% (15 g, 60 g)
Shampoo, External, as acetonide:
Capex: 0.01% (120 mL)
Solution, External, as acetonide:
Synalar: 0.01% (60 mL [DSC], 90 mL [DSC]) [contains propylene glycol]
Generic: 0.01% (60 mL)
May be product dependent
Cream (Fluocinolone Acetonide External)
0.01% (per gram): $2.99
0.025% (per gram): $2.99
Cream (Synalar External)
0.025% (per gram): $6.27
Oil (Derma-Smoothe/FS Body External)
0.01% (per mL): $0.37
Oil (Derma-Smoothe/FS Scalp External)
0.01% (per mL): $0.35
Oil (Fluocinolone Acetonide Body External)
0.01% (per mL): $0.37 - $1.87
Oil (Fluocinolone Acetonide Scalp External)
0.01% (per mL): $0.94 - $1.89
Ointment (Fluocinolone Acetonide External)
0.025% (per gram): $2.25 - $2.26
Ointment (Synalar External)
0.025% (per gram): $6.27
Shampoo (Capex External)
0.01% (per mL): $3.82
Solution (Fluocinolone Acetonide External)
0.01% (per mL): $0.66 - $3.13
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as acetonide:
Fluoderm: 0.01% ([DSC]); 0.025% ([DSC])
Oil, External:
Derma-Smoothe/FS: 0.01% (118 mL, 120 mL, 355 mL) [contains alcohol, usp, peanut oil]
Ointment, External:
Synalar Mild: 0.01% (60 g)
Ointment, External, as acetonide:
Fluoderm: 0.025% ([DSC])
Synalar: 0.025% (60 g)
Solution, External, as acetonide:
Synalar: 0.01% ([DSC])
Topical: Not for oral, ophthalmic, or intravaginal use; do not apply to the face, axillae, or groin unless directed by healthcare provider.
Body oil: Apply the least amount necessary to cover the affected area; do not apply to intertriginous areas.
Cream, ointment, topical solution: Apply sparingly in a thin film; rub in lightly. In hairy sites, the hair should be parted to allow direct contact with the lesion. Occlusive dressings may be helpful in managing psoriasis or recalcitrant conditions, but should not be used if an infection develops.
Shampoo: Shake well before use; do not bandage, wrap, or cover treated scalp area unless directed by healthcare provider.
Synalar cream, ointment, topical solution: Apply sparingly in a thin film; rub in lightly. In hairy sites, the hair should be parted to allow direct contact with the lesion.
Derma-Smoothe/FS (body oil, scalp oil): Do not apply to face or diaper area; avoid application to intertriginous areas (may increase local adverse effects)
Body oil: Treatment of moderate to severe atopic dermatitis in pediatric patients ≥3 months; treatment of atopic dermatitis in adults
Cream, ointment, topical solution: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Scalp oil: Treatment of psoriasis of the scalp in adults
Shampoo: Treatment of seborrheic dermatitis of the scalp
Capex may be confused with Kapidex [DSC]
Fluocinolone may be confused with fluocinonide
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
There are no known significant interactions.
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
Systemic bioavailability of topical corticosteroids is variable (integrity of skin, use of occlusion, etc) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
It is not known if sufficient quantities of fluocinolone are absorbed following topical administration to produce detectable amounts in breast milk. However, systemic corticosteroids are present in breast milk.
Although the manufacturer recommends that caution be used, topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding, then clean nipples prior to the next feeding (Vestergaard 2019).
Growth in pediatric patients; HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); signs of bacterial or fungal infection
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Fluocinolone has low to intermediate range potency (dosage-form dependent).
Absorption: Dependent on formulation, amount applied, nature of skin at application site; may be increased with inflammation or occlusion
Metabolism: Hepatic
Excretion: Primarily urine; bile
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