1. NATURE OF THIS DOCUMENT. This is a legally binding informed consent for the off-label use of four compounded medications prescribed by David Mahjoubi, MD, through NutraBrain Clinic, Inc. d/b/a Dr. David Wellness (drdavidwellness.com): (a) RevNRepair topical cream (Tazarotene 0.05% + Rapamycin 0.05%); (b) Oxytocin nasal spray; (c) FollicaRx topical hair serum (Minoxidil, Ketoconazole, Latanoprost, Niacinamide, Vitamin E); and (d) NexArouse sublingual tablets (Apomorphine/Sildenafil/Oxytocin). Read every section before signing. If anything is unclear, stop and contact our office at (818) 570-1640 or dr@nutrabrainclinic.com before signing.
2. COMPOUNDING AND OFF-LABEL DISCLOSURE. Each product is a pharmaceutical-grade compounded medication prepared by a licensed compounding pharmacy and is NOT FDA-approved as a finished product. While several individual ingredients are FDA-approved for related uses, their use in these formulations and for skin rejuvenation, hair, mood, bonding, libido, and sexual wellness is OFF-LABEL. Off-label prescribing by a licensed physician is legal but means the FDA has not evaluated these specific uses. I will not substitute or supplement my prescriptions with non-prescription versions purchased elsewhere.
3. PREGNANCY AND BREASTFEEDING — CRITICAL WARNING. This bundle must NOT be used if I am pregnant, may be pregnant, am trying to become pregnant, or am breastfeeding. Tazarotene (in RevNRepair) is FDA Pregnancy Category X and can cause severe birth defects. Oxytocin (in the nasal spray and in NexArouse) is a uterotonic hormone that can stimulate uterine contractions and may cause miscarriage, premature labor, or fetal harm, and can affect breastfeeding. Minoxidil and latanoprost are also not recommended in pregnancy. If I am able to become pregnant, I will use reliable contraception during treatment and for at least one month after stopping tazarotene, and I will stop the products and notify the clinic immediately if I become pregnant or suspect I may be.
4. TELEHEALTH RELATIONSHIP. This is a telehealth prescribing relationship. Dr. Mahjoubi has not physically examined me and evaluates me only by questionnaire, secure messaging, telephone, or video. Telehealth depends entirely on the accuracy and completeness of the information I provide. I am responsible for accurately disclosing my full medical history, all medications and supplements, and any changes during treatment. Dr. Mahjoubi prescribes only in states where he is licensed. This relationship is limited to prescribing these products and related follow-up and does not make Dr. Mahjoubi my primary care physician; I will continue routine care with my own physician.
5. REVNREPAIR (Tazarotene/Rapamycin topical) — RISKS. Evening use only, on intact skin; avoid eyes, mouth, nostrils, and broken or sunburned skin. Common effects include peeling, dryness, redness, burning, and stinging, especially in the first 2–4 weeks; skin may appear to worsen before improving. UV SENSITIVITY: tazarotene significantly increases sun sensitivity for several days after each application; I will apply broad-spectrum SPF 30+ every morning, reapply as needed, and limit sun exposure to avoid severe sunburn and hyperpigmentation. I will not use other retinoids or strong exfoliants at the same time. Rapamycin is an mTOR inhibitor; topical absorption is expected to be minimal, but there is a theoretical risk of local immunosuppression and skin infection, and I will report unusual redness, warmth, pus, or non-healing sores. PREGNANCY CATEGORY X applies as stated in Section 3.
6. OXYTOCIN NASAL SPRAY — RISKS. Possible effects include nasal irritation or congestion, headache, nausea, flushing, drowsiness, transient changes in blood pressure or heart rate, and changes in mood including emotional sensitivity, tearfulness, or — paradoxically — increased anxiety in some patients. With high or repeated dosing or excessive water intake, oxytocin can rarely cause low blood sodium (hyponatremia) with confusion, severe headache, or seizures. It is contraindicated in pregnancy/breastfeeding (Section 3), uncontrolled cardiovascular disease, active or unstable severe psychiatric illness, significant hyponatremia/SIADH/severe kidney disease, certain nasal conditions, and known allergy to oxytocin or its preservatives. It can interact dangerously with ergot-derivative migraine medications and vasoconstrictors (risk of severe high blood pressure); I have disclosed these. I will not drive or perform safety-sensitive tasks within 2 hours of a dose.
7. FOLLICARX (topical hair serum) — RISKS. External scalp use only; avoid the eyes. MINOXIDIL may cause scalp irritation, unwanted facial hair, dizziness, rapid heartbeat, swelling, or chest pain. LATANOPROST may cause skin/eyelash darkening and, rarely if it contacts the eye, permanent iris color change; I will avoid eye contact and wash my hands after applying. KETOCONAZOLE may cause itching, dryness, or rare allergic reaction. FollicaRx is non-hormonal and contains no finasteride.
8. NEXAROUSE (Apomorphine/Sildenafil/Oxytocin) — RISKS. SILDENAFIL interacts dangerously with nitrates and guanylate cyclase stimulators (riociguat) and can cause life-threatening low blood pressure; I confirm I do not use these. Sildenafil can rarely cause sudden vision loss (NAION) or sudden hearing loss. Its use for female sexual wellness is off-label. APOMORPHINE can cause severe nausea/vomiting, sudden blood pressure drops with fainting, drowsiness, and rare impulse-control disorders (compulsive gambling, hypersexuality, shopping, or eating); I or my partner will watch for new urges and stop if they occur. OXYTOCIN in this tablet carries the pregnancy contraindication in Section 3. I will not combine NexArouse with alcohol, opioids, or sedatives, and will not drive or operate machinery for at least 6 hours after a dose or until any dizziness resolves.
9. EMERGENCY ACTION PLAN. I will stop the relevant product(s) and call 911 or go to the nearest ER for: chest pain, fainting, irregular heartbeat, or sudden severe headache; sudden vision or hearing loss; confusion or seizure; difficulty breathing or swelling of the face, lips, tongue, or throat; severe persistent nausea or vomiting; a severe skin or allergic reaction; or, if pregnant or possibly pregnant, any abdominal cramping or vaginal bleeding. I will then notify Dr. Mahjoubi's office. If I have thoughts of self-harm, I will call or text 988.
10. NO GUARANTEE OF BENEFIT. No guarantee, express or implied, has been made that I will experience any specific benefit from any product in this bundle. Individual response varies. No specific outcome has been promised.
11. FINANCIAL TERMS AND REFUND POLICY. The Women's Renewal Stack fee is $495, shipping included, covering physician evaluation, prescription, and the compounded medications. Because these are custom-compounded prescription medications, they cannot be returned or refunded once dispensed and shipped, except for damaged or incorrect orders reported within 48 hours of delivery. Submission and payment do NOT guarantee a prescription; if the physician determines I am not an appropriate candidate, my order will be canceled and refunded.
12. PRIVACY, COMMUNICATIONS, AND ADVERSE EVENTS. NutraBrain Clinic, Inc. d/b/a Dr. David Wellness operates in accordance with HIPAA; the Notice of Privacy Practices and Terms of Service are at drdavidwellness.com. I authorize communication by email, secure portal, telephone, and text and accept the inherent privacy risks of email and text; I may opt out of non-essential messages by replying STOP. I authorize transmission of my prescriptions to the compounding pharmacy. Dr. Mahjoubi may report adverse events to FDA MedWatch (www.fda.gov/medwatch, 1-800-FDA-1088) and the pharmacy as permitted by law.
13. VOLUNTARY CONSENT, RELEASE, AND GOVERNING LAW. My consent is voluntary and without coercion. I may withdraw and discontinue at any time, subject to non-refundability of medication already shipped. I accept full responsibility for my decision to use these products and agree to hold David Mahjoubi, MD, and NutraBrain Clinic, Inc. d/b/a Dr. David Wellness harmless from any adverse outcome arising from my failure to disclose accurate information or follow instructions, except in cases of gross negligence or willful misconduct. This consent does not waive any of my legal rights and is governed by the laws of the State of California except where applicable law requires otherwise (e.g., state medical board complaints). I am at least 18 years old, of sound mind, and legally competent to consent.