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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded topical cream containing fluocinolone acetonide, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing fluocinolone are listed in cream, oil, solution, ointment and implant forms.
This dose form is water-containing (aqueous). Under USP <795>, aqueous preparations carry shorter default beyond-use dates than nonaqueous ones, and a preservative in the base allows a longer date than no preservative. The date printed on the label is the one to follow.
Fluocinolone is a corticosteroid used on the skin and scalp that a pharmacy may compound when a prescriber orders it.
Fluocinolone acetonide is a synthetic corticosteroid. Topical corticosteroids calm inflammation in several ways, including narrowing small blood vessels in the skin and reducing the production of prostaglandins and leukotrienes. Manufactured topical products include Synalar cream, indicated for the inflammatory and itchy symptoms of corticosteroid-responsive skin conditions; Derma-Smoothe/FS Scalp Oil, indicated for scalp psoriasis in adults; and DermOtic Oil, indicated for chronic eczematous external otitis. Fluocinolone is also made as eye implants, Yutiq and Iluvien, for chronic non-infectious uveitis of the back of the eye, and Iluvien also for diabetic macular edema. A prescriber might order fluocinolone compounded in a strength, vehicle or combination that is not manufactured. Compounded preparations are not FDA-approved and require a prescription.
Topical fluocinolone has no boxed warning. Its label warns that corticosteroids absorbed through the skin can suppress the body's own steroid production (the HPA axis) and can cause Cushing's syndrome and high blood sugar, especially with large areas, long use, occlusion, damaged skin, liver failure or young age. Local effects include skin thinning, stretch marks, irritation, acne-like bumps, lightening of the skin and allergic contact dermatitis. Glaucoma and cataracts have been reported, so keep it away from the eyes. It can delay healing of skin infections. Derma-Smoothe/FS contains refined peanut oil. MedlinePlus advises avoiding the face, groin and skin folds, and not wrapping the area, unless directed. In pregnancy and breastfeeding, the label advises the smallest area for the shortest time and no application to the nipple or areola. Talk to your prescriber or pharmacist about side effects.
Topical corticosteroids act through anti-inflammatory, antimitotic and immunosuppressive mechanisms, including dermal vasoconstriction, lipocortin-mediated inhibition of phospholipase A2, and suppression of inflammatory transcription factors such as NF-kB. In vasoconstrictor studies, Derma-Smoothe/FS ranks in the low to medium potency range. Percutaneous absorption depends on the vehicle, the integrity of the epidermal barrier, occlusion and inflammation; absorbed drug is metabolized mainly in the liver and excreted by the kidneys, with some biliary excretion. Labeled uses: corticosteroid-responsive dermatoses (Synalar cream), scalp psoriasis in adults (Derma-Smoothe/FS), chronic eczematous external otitis (DermOtic Oil), chronic non-infectious posterior uveitis (Yutiq, Iluvien) and diabetic macular edema in previously treated patients without a clinically significant intraocular pressure rise (Iluvien). Dosing is per prescriber. Consider periodic evaluation for HPA axis suppression with extensive or occlusive use, and an ACTH stimulation test if suspected. Use caution in patients with peanut sensitivity when prescribing products formulated with peanut oil. LactMed notes fluocinolone has not been studied in breastfeeding and favors the least potent agent on the smallest area.
Wash your hands. Apply the amount on your label to clean, dry skin and rub it in gently. For a metered pump, each press delivers a set amount; your label states how many presses. For transdermal creams, apply to the area your label names and let it dry before dressing. Wash your hands afterward and avoid skin-to-skin contact with others at the application site until it has absorbed. Do not apply to broken skin unless told to.
Creams are aqueous. Under USP <795>, a preserved cream usually carries a beyond-use date of up to 35 days at room temperature or refrigerated, and an unpreserved one 14 days refrigerated. Follow the storage line on your label, keep from freezing, keep out of reach of children, and discard after the beyond-use date.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Apply topically to affected area(s)
