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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 shampoo containing tea tree oil, 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 tea tree oil is listed. Products containing it are filed in the directory as over-the-counter monograph drugs, unapproved drugs and homeopathic products, in liquid, patch, soap, cream and cloth forms. None of the listed products containing tea tree oil is in shampoo form.
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.
Tea tree oil is a plant essential oil with antimicrobial properties; compounding pharmacies prepare it in topical creams, ointments, washes and nail solutions.
Tea tree oil is the volatile oil steam-distilled from the leaves of Melaleuca alternifolia, a tree native to New South Wales and Queensland, Australia. It is a mixture of terpene hydrocarbons and alcohols, with terpinen-4-ol as the main constituent and more than 100 others; the ISO 4730 standard sets limits for its major components. Its antimicrobial activity is why it appears in topical products for skin infections. No FDA-approved tea tree oil drug exists. DailyMed lists OTC shampoos, soaps and creams that carry tea tree oil in their names but rely on other active ingredients such as pyrithione zinc or tolnaftate, as well as labeler-submitted OTC nail and skin products that name tea tree oil as the active ingredient; a DailyMed listing does not mean FDA has reviewed or approved the product. A prescriber may order tea tree oil compounded at a defined concentration in a specific vehicle, alone or combined with an antifungal, antibacterial or keratolytic agent. Compounded preparations are not FDA-approved and require a prescription.
Tea tree oil has no FDA label and no boxed warning. It must never be swallowed: oral ingestion has caused confusion, unsteadiness, inability to walk and coma, and poisoning cases in children and adults have been reported, all recovering with supportive care. On skin it can cause irritation or allergic reactions, more likely with undiluted oil and with old products or oil exposed to heat, light or air; a 2006 review argues against using neat oil. Tea tree oil has shown estrogenic and anti-androgenic activity in the laboratory, and breast enlargement in boys has been reported after topical exposure; the relevance of these reports is disputed and unconfirmed. NCCIH states topical products may be safe during pregnancy and breastfeeding; LactMed says no data exist in nursing mothers or infants and that application around the breast should be avoided unless thoroughly removed before nursing. No drug interactions are described in the sources read. If redness, itching or a rash develops, stop use and talk to your prescriber or pharmacist.
Tea tree oil is composed of monoterpenes, sesquiterpenes and their alcohols; terpinen-4-ol is the dominant constituent per ISO 4730, with gamma-terpinene, alpha-terpinene and 1,8-cineole among the others. Pharmacokinetic data on dermal absorption were not found in the sources read. In vitro activity against a wide range of bacteria including MRSA, yeasts and dermatophytes is documented (Carson 2006). No labeled indications exist. Prescribers have ordered compounded tea tree oil for acne, tinea pedis, onychomycosis, seborrheic dermatitis and Demodex blepharitis; NCCIH summarizes the evidence as small studies suggesting possible benefit in acne and athlete's foot, with too few quality studies in nail fungus and uncertain findings for lice, Demodex and mouth rinses. The Carson review tabulates an investigator-blinded acne trial of a tea tree gel against benzoyl peroxide in which both reduced inflamed lesions, benzoyl peroxide more so, with fewer adverse events in the tea tree group. Concentration, vehicle and duration are per prescriber. Monitoring: local irritation and allergic contact dermatitis; avoid periocular or mucosal application unless formulated for it; counsel against ingestion and keep out of reach of children. Not a controlled substance.
Wet your hair and scalp well. Apply enough shampoo to work up a lather and massage it gently over the whole scalp. Leave it in place for the time on your label, often several minutes, then rinse well with warm water. Keep it out of your eyes. Use it as often as your label directs and wash your hands afterward.
Shampoos are aqueous. Under USP <795>, a preserved shampoo usually carries a beyond-use date of up to 35 days at room temperature or refrigerated, and an unpreserved one 14 days refrigerated. Keep the bottle closed, keep from freezing, keep 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)
