RevNRepair - Topical Rejuvenation
Rapamycin + Tazarotene all in one cream OR Kit with Rapamycin, Tazarotene, VersaPro moisturizer
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INFORMED CONSENT FOR TOPICAL SKIN REJUVENATION KITRevNRepairTM Skin Renewal PackagePRESCRIBING PHYSICIANDavid Mahjoubi, MDDr David Wellness, Inc.www.drdavidwellness.comPRODUCT DESCRIPTIONRevNRepair is a physician-curated topical skin rejuvenation package designed for anti-aging, skin textureimprovement, and cellular renewal. The kit contains the following three products, which are intended to be usedtogether as part of a coordinated skin care regimen:• Tazarotene 0.05% Topical Cream – A prescription retinoid (vitamin A derivative) that promotes skin cellturnover, reduces fine lines and wrinkles, improves skin texture and tone, and may help diminishhyperpigmentation. Tazarotene is FDA-approved for the treatment of acne and plaque psoriasis, and is usedoff-label for photoaging and skin rejuvenation.• Rapamycin (Sirolimus) 0.2% Topical Cream – A compounded topical formulation of rapamycin, an mTORinhibitor. Topical rapamycin is being explored for its potential anti-aging properties at the cellular level, includingpromoting autophagy (cellular self-renewal) and improving skin quality. This is a compounded medication and isnot FDA-approved for cosmetic or anti-aging use. Its use in this context constitutes off-label prescribing.• La Roche-Posay Lipikar Repair Cream – An over-the-counter moisturizing and skin barrier repair cream. Thisproduct is included in the kit as a mixing agent to be combined with the tazarotene cream at the time ofapplication to help reduce irritation, dryness, and next-day redness commonly associated with retinoid use. LaRoche-Posay Lipikar is a commercially manufactured product and is not a prescription medication. IMPORTANT: UV SENSITIVITY WARNING Tazarotene significantly increases your skin's sensitivity to ultraviolet (UV) radiation. Your skin will bemore susceptible to sunburn, sun damage, and photosensitivity reactions for several days after eachapplication. You MUST apply broad-spectrum sunscreen (SPF 30 or higher) every morning and reapplyas directed, wear protective clothing, and minimize direct sun exposure while using this product. Failureto protect your skin from UV radiation during retinoid therapy may result in severe sunburn, increasedhyperpigmentation, and accelerated skin damage — the opposite of the intended effect.RISKS, SIDE EFFECTS, AND WARNINGSI understand and acknowledge the following risks and potential side effects associated with the use of theRevNRepair kit:• Skin Irritation and Retinoid Dermatitis: Tazarotene commonly causes skin peeling, dryness, redness,burning, stinging, and irritation, especially during the first 2–4 weeks of use. This is sometimes referred to as the"retinoid purge" or "retinization period." While mixing with La Roche-Posay Lipikar cream may reduce theseeffects, irritation may still occur.• Photosensitivity and Sun Damage: As described above, tazarotene makes the skin significantly moresensitive to UV radiation for several days after each application. Exposure to sunlight, tanning beds, or UV lightwithout adequate sun protection may cause severe sunburn, blistering, hyperpigmentation, or increased risk ofskin damage. I agree to use daily broad-spectrum sunscreen (SPF 30+) and limit sun exposure while using thisproduct.• Allergic Reactions: I may experience an allergic reaction to one or more of the active or inactive ingredients inany of the three products, including but not limited to rash, hives, itching, swelling, blistering, difficulty breathing,or anaphylaxis. If I experience signs of a severe allergic reaction, I will discontinue use immediately and seekemergency medical attention.• Contact Sensitization: Prolonged or repeated use of any topical product may cause contact sensitization orcontact dermatitis. I will notify my physician if I develop a persistent or worsening rash at the application site.• Systemic Absorption: Although these products are applied topically, active ingredients may be absorbedthrough the skin. Systemic absorption of tazarotene or rapamycin, while expected to be minimal with topicalapplication, could potentially cause effects beyond the skin. I will report any unusual systemic symptoms to myphysician.• Rapamycin-Specific Risks: Rapamycin (sirolimus) is an immunosuppressant when taken systemically. Whiletopical application at 0.2% concentration is expected to result in minimal systemic absorption, there is atheoretical risk of localized immunosuppression at the application site, which could potentially increasesusceptibility to skin infections. I will report any signs of infection (unusual redness, warmth, pus, or non-healingsores) to my physician promptly.• Pregnancy and Teratogenicity – CRITICAL WARNING: Tazarotene is classified as FDA PregnancyCategory X. It is known to cause severe birth defects and MUST NOT be used by women who are pregnant,may become pregnant, or are planning to become pregnant. Women of childbearing potential must use effectivecontraception during treatment and for at least one month after discontinuation. If I am female and becomepregnant while using this product, I will discontinue use immediately and notify my physician.• Drug and Product Interactions: Tazarotene may interact with other topical products, particularly thosecontaining alpha hydroxy acids (AHAs), beta hydroxy acids (BHAs), benzoyl peroxide, salicylic acid, or otherretinoids. Concurrent use of multiple irritating products may cause excessive dryness, peeling, or irritation. I havedisclosed all topical products and medications I am currently using.• Skin Discoloration: Temporary changes in skin color (hyperpigmentation or hypopigmentation) may occur,particularly in individuals with darker skin tones. These changes are usually reversible upon discontinuation butmay persist in some cases.• Initial Worsening: Skin condition may appear to worsen before improving, particularly during the first fewweeks of retinoid use. This is a known effect of increased cell turnover and does not necessarily indicate anadverse reaction.INSTRUCTIONS FOR USEI have received and understand the following instructions for using the RevNRepair kit:1. Apply tazarotene cream in the evening only (never in the morning before sun exposure).2. Mix a pea-sized amount of tazarotene 0.05% cream with an equal or slightly larger amount of La Roche-PosayLipikar Repair Cream in the palm of my hand before applying to the face or treatment area. This "buffering"technique helps reduce irritation and next-day redness.3. Apply rapamycin 0.2% cream to the treatment area as directed by my physician, either before or after thetazarotene/Lipikar mixture, or on alternate evenings as prescribed.4. Apply broad-spectrum sunscreen (SPF 30 or higher) every morning, regardless of weather or plans to beoutdoors. Reapply every 2 hours during prolonged sun exposure.5. Avoid applying tazarotene to broken, sunburned, eczematous, or irritated skin.6. Avoid contact with eyes, mouth, mucous membranes, and open wounds.7. Start slowly (e.g., every other evening or every third evening) and gradually increase frequency as tolerated,per physician guidance.8. Keep all products out of reach of children.NO GUARANTEE OF RESULTSI understand and acknowledge that there is no guarantee that RevNRepair will reduce wrinkles, improve skintexture, reverse signs of aging, or achieve any specific cosmetic or therapeutic outcome. Results vary frompatient to patient and are influenced by many factors including age, skin type, genetics, sun exposure history,compliance with instructions, and concurrent skin care practices. This product may not produce visible results for allpatients. My physician has made no promises or guarantees regarding the outcome of this treatment.COMPOUNDING AND OFF-LABEL USE DISCLOSUREI understand that the rapamycin 0.2% topical cream included in this kit is a compounded medication and is notFDA-approved for cosmetic or anti-aging use. Compounded medications have not undergone the same rigoroustesting for safety, efficacy, and manufacturing consistency as FDA-approved products. The FDA does not verify thesafety or effectiveness of compounded drugs. I also understand that the use of tazarotene for anti-aging and skinrejuvenation may constitute off-label use. Off-label prescribing is a legal and commonly accepted medical practicewhen a physician determines it is in the patient's best interest. I consent to this off-label and compounded use afterbeing informed of the potential risks and benefits.ASSUMPTION OF RISK AND LIMITATION OF LIABILITYBy signing below, I voluntarily assume all risks associated with the use of RevNRepair. I agree that Dr DavidWellness, Inc., David Mahjoubi, MD, and their officers, employees, agents, and affiliates shall not be held liable forany adverse reactions, side effects, injuries, damages, or losses arising from the use, misuse, or inability to use thisproduct, except to the extent caused by gross negligence or willful misconduct. I understand that I use this product atmy own risk and that my decision to proceed is made freely and voluntarily after being fully informed. I furtheracknowledge that the La Roche-Posay Lipikar Repair Cream is a third-party commercial product and that Dr DavidWellness, Inc. is not the manufacturer of said product and bears no liability for defects, adverse reactions, or issuesrelated to its formulation or manufacturing.PATIENT ACKNOWLEDGMENTS1. I have read and understand this entire Informed Consent form.2. I have had the opportunity to ask questions about RevNRepair, its ingredients, risks, benefits, and alternatives,and my questions have been answered to my satisfaction.3. I have disclosed to my prescribing physician all known allergies, medical conditions, skin conditions, andcurrent medications and topical products.4. I understand that tazarotene makes my skin significantly more sensitive to UV radiation for severaldays after each application and I commit to using daily sunscreen (SPF 30+) and limiting sun exposure.5. If I am female, I confirm that I am NOT pregnant, do NOT plan to become pregnant during treatment, and willuse effective contraception while using tazarotene. I understand that tazarotene is Pregnancy Category X andcan cause severe birth defects.6. I understand that I may discontinue use of these products at any time and should contact my physician if Iexperience any adverse effects.7. I consent to the prescribing and use of the RevNRepair kit as described herein.8. I acknowledge that this consent form does not waive any of my legal rights.9. I agree to follow all instructions for use provided by my physician, including the mixing technique, evening-onlyapplication of tazarotene, and daily sunscreen use.10. I understand that initial skin irritation, peeling, and redness are expected with retinoid use and do notnecessarily constitute an adverse reaction requiring discontinuation
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List all prescription medications currently being taken, dosages not needed; if none please write "none."
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What are you seeking RevNRepair for?
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Anti-aging
Skin Texture
Rosacea
Other
If you have any of the following, please write the condition below: Immunosuppresion such as chemotherapy recipient or AIDS, organ transplant recipient, active cancer, autoimmune disease, active skin condition or open wound on intended site of application, inflammatory skin condition, history of skin cancer such as melanoma, basal or squamous cell carcinoma, uncontrolled diabetes, currently pregnant or breast feeding. If none please write "none."
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Are you taking any of the following medications:
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Please Select
Ketoconazole
Flucanazole
Rifampin
Clarithromycin
Erythromycin
St Johns Wort
None of the above
Are you currently using retinoids, tretinoin, alpha hydroxy acids, or other exfoliants at the intended treatment site? Barrier disruption increases absorption.
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No
Yes
Please list all medication allergies in the box below- if none please write "none." If you are allergic to Rapamycin, Sirolimus, Macrolide Antibiotics, or sorbitol, stop and do not complete this form.
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RevNRepair - Topical Rejuvenation
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Box Containing Tazarotene 0.05% -30 grams, Rapamycin 0.05% - 30 grams, and VersaPro Moisturizer (all in separate dispensers)
$
375.00
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Combined Tazarotene 0.05% + Rapamycin 0.05% in Versatile Anhydrous Cream - 30 grams
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250.00
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Combined Tazarotene 0.05% + Rapamycin 0.05% in Versatile Anhydrous Cream - 60 grams
$
375.00
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You understand that Rapamycin and Tazarotene are not FDA approved for "anti-aging."
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