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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 gel containing clioquinol, 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.
No FDA-approved (NDA or ANDA) product containing clioquinol is listed. The only finished clioquinol product in the directory is an over-the-counter monograph cream that also contains hydrocortisone. None of the listed products containing clioquinol is in gel form.
Gel bases can be aqueous or nonaqueous, and USP <795> classifies the preparation by its water activity. Aqueous preparations carry shorter default beyond-use dates than nonaqueous ones. The date printed on the label is the one to follow.
Clioquinol (iodochlorhydroxyquin) is a topical antifungal and antibacterial agent applied to the skin that a pharmacy may compound when a prescriber orders it.
Clioquinol, also called iodochlorhydroxyquin, is a halogenated 8-hydroxyquinoline that acts against fungi and bacteria and binds (chelates) metals such as zinc and copper. It was first produced as a topical antiseptic and was marketed as an oral intestinal amebicide from 1934, but oral use was withdrawn in the early 1970s after it was linked to subacute myelo-optic neuropathy (SMON), a nerve and vision disorder. FDA's OTC Monograph M005 lists clioquinol as a topical antifungal active ingredient for athlete's foot, jock itch and ringworm. MedlinePlus states that clioquinol topical is no longer available in the United States. Drugs@FDA lists one application, a clioquinol and nystatin ointment (Nystaform), as discontinued. DailyMed lists two OTC skin products containing clioquinol from one labeler. A prescriber might order clioquinol compounded for the skin. Compounded preparations are not FDA-approved and require a prescription.
Clioquinol skin products carry no boxed warning. Under the OTC antifungal monograph, clioquinol products must warn: do not use on children under 2 years of age, and do not use for diaper rash. It is for external use only; keep it out of the eyes and mouth and do not swallow it. Do not use it if you are allergic to clioquinol or any ingredient. MedlinePlus notes it can stain clothing, hair, skin and nails yellow, and that you should tell your prescriber before a thyroid function test. Call your prescriber if itching, burning, stinging, redness or swelling occurs. Oral clioquinol was withdrawn after being linked to a serious nerve disorder, so this ingredient is only for use on the skin as prescribed. If you are pregnant or breastfeeding, ask your prescriber before use. Talk to your prescriber or pharmacist about side effects.
Clioquinol (5-chloro-7-iodo-8-quinolinol) is a zinc and copper chelator with antifungal and antibacterial activity. Per a review by Bareggi and Cornelli (CNS Neurosci Ther 2012), it was marketed as an oral intestinal amebicide from 1934 for conditions including lambliasis, shigellosis and nonspecific diarrhea, and was withdrawn as an oral agent in the early 1970s because of its association with SMON, characterized by symmetrical demyelination of the lateral and posterior spinal cord columns, optic nerve and peripheral nerves. SMON affected about 10,000 people in Japan and was extremely rare elsewhere; the review notes the causal evidence is circumstantial and that concomitant vitamin B deficiency has been proposed. Because of metal chelation, clioquinol has been studied in neurodegenerative disorders such as Alzheimer's disease, which is not an FDA-approved indication. Current regulatory status: OTC Monograph M005 permits topical clioquinol for athlete's foot, jock itch and ringworm, with required warnings against use under age 2 and for diaper rash. MedlinePlus states the topical product is no longer available in the US, and the only Drugs@FDA application is discontinued. MedlinePlus advises patients to tell their prescriber before a thyroid function test. Dosing is per prescriber.
Wash your hands. Apply the amount on your label to clean, dry skin and spread it in a thin layer. For a metered pump, your label states the number of presses. For a dosing syringe, push the plunger to the mark. Let the gel dry before covering with clothing. Wash your hands afterward and keep the site from touching other people until it has dried. Do not apply to broken skin unless told to.
A gel can have a nonaqueous or a water-based base, and USP <795> sets its default beyond-use date by water content, not by the word gel. A nonaqueous gel usually carries a beyond-use date of up to 180 days at room temperature or refrigerated. A water-based gel carries up to 35 days with a preservative, or 14 days refrigerated without one. Your label states which applies. Keep the container closed, away from heat and open flame if it contains alcohol, out of reach of children, and discard after the beyond-use date on your label.
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)
