Pain Away Pro
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Dr David Wellness, Inc.www.drdavidwellness.comINFORMED CONSENT FOR COMPOUNDED TOPICAL MEDICATIONPain Away ProTM Topical CreamPRESCRIBING PHYSICIANDavid Mahjoubi, MDDr David Wellness, Inc.www.drdavidwellness.comPRODUCT DESCRIPTIONPain Away Pro is a physician-prescribed compounded topical cream formulated for the management of pain. Thisproduct is prepared by a licensed compounding pharmacy and is not an FDA-approved drug product. Compoundedmedications are customized preparations made to meet the specific needs of individual patients when commerciallymanufactured products are not suitable or available.ACTIVE INGREDIENTSPain Away Pro contains the following active pharmaceutical ingredients. By signing this form, you acknowledge thatyou have been informed of each ingredient and its general purpose:• Ketamine – An NMDA receptor antagonist used for its analgesic (pain-relieving) properties.• Lidocaine – A local anesthetic that numbs the area of application to reduce pain sensation.• Diclofenac – A nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain.• Menthol – A naturally derived counterirritant that produces a cooling sensation to alleviate pain.• Clonidine – An alpha-2 adrenergic agonist that may reduce pain signaling and inflammation.• Baclofen – A muscle relaxant and antispastic agent that may reduce muscle-related pain.• Amitriptyline – A tricyclic compound used topically for its analgesic properties in nerve-related pain.RISKS, SIDE EFFECTS, AND WARNINGSI understand and acknowledge the following risks and potential side effects associated with the use of Pain Away Pro:• Allergic Reactions: I may experience an allergic reaction to one or more of the active or inactive ingredients inthis product, including but not limited to skin rash, hives, itching, redness, swelling, blistering, difficulty breathing,or anaphylaxis. If I experience any signs of a severe allergic reaction, I will discontinue use immediately and seekemergency medical attention.• Local Skin Reactions: Application site reactions may include burning, stinging, tingling, numbness, redness,dryness, irritation, or dermatitis. These may be temporary or persistent.• Systemic Absorption: Although this is a topical product, active ingredients may be absorbed through the skininto the bloodstream, particularly when applied to large areas, broken or damaged skin, or under occlusivedressings. Systemic absorption may cause dizziness, drowsiness, sedation, changes in blood pressure, heartrate changes, nausea, or other systemic effects.• Drug Interactions: The ingredients in this product may interact with other medications I am currently taking,including but not limited to blood pressure medications, sedatives, other pain medications, antidepressants,blood thinners, and other topical products. I have disclosed all current medications to my prescribing physician.• Special Populations: This product has not been specifically studied in pregnant or nursing women, children, orelderly patients. If I am or become pregnant, am breastfeeding, or am applying this product to a minor or elderlyindividual, I will notify my physician immediately.• Misuse and Accidental Exposure: This product is for external topical use only. I will avoid contact with eyes,mucous membranes, open wounds, and will keep this product out of reach of children and pets. Accidentalingestion may be harmful or fatal.NO GUARANTEE OF RESULTSI understand and acknowledge that there is no guarantee that Pain Away Pro will provide pain relief orachieve any specific therapeutic outcome. Results vary from patient to patient. Pain management is complex andinfluenced by many factors. This product may not work for all types of pain and may not be effective for my particularcondition. The decision to use this product does not guarantee a cure, reduction in symptoms, or improvement in mycondition. My physician has made no promises or guarantees regarding the outcome of this treatment.COMPOUNDING DISCLOSUREI understand that Pain Away Pro is a compounded medication and is not FDA-approved. Compounded medicationshave not undergone the same rigorous testing for safety, efficacy, and manufacturing consistency as FDA-approvedproducts. The FDA does not verify the safety or effectiveness of compounded drugs. I accept this product with theunderstanding that it is prepared specifically for me based on a valid prescription.ASSUMPTION OF RISK AND LIMITATION OF LIABILITYBy signing below, I voluntarily assume all risks associated with the use of Pain Away Pro. 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.PATIENT ACKNOWLEDGMENTS1. I have read and understand this entire Informed Consent form.2. I have had the opportunity to ask questions about Pain Away Pro, its ingredients, risks, benefits, andalternatives, and my questions have been answered to my satisfaction.3. I have disclosed to my prescribing physician all known allergies, medical conditions, and current medications(including over-the-counter products and supplements).4. I understand that I may discontinue use of this product at any time and should contact my physician if Iexperience any adverse effects.5. I consent to the prescribing and use of Pain Away Pro as described herein.6. I acknowledge that this consent form does not waive any of my legal rights.7. I agree to follow all instructions for use provided by my physician and/or pharmacist
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Pain Away Pro
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Pain Away Pro
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Where is your pain located?
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Describe the character of your pain (e.g., burning, aching, sharp, throbbing, numbness/tingling).
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Burning
Aching
Sharp
Throbbing
Numbness
Tingling
Please list all current medications, including prescription drugs, over-the-counter medications, and supplements.Dosage not needed. If none please write "none."
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Do you have any known drug allergies or sensitivities? If yes, please describe the reaction.If none please write "none."
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What treatments have you previously tried for this pain? (e.g., physical therapy, oral medications, injections, other topical creams)
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Physical Therapy
Oral medications
Injections
Other topical creams
Is the skin at your intended application site intact and free of open wounds, rashes, or active skin conditions?
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No
Yes
Are you currently pregnant, breastfeeding, or actively trying to conceive?
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No
Yes
Have you been diagnosed with cancer in the past 5 years, or are you currently undergoing cancer treatment?
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No
Yes
By signing this box, I confirm that I understand PainAway Pro™ is a compounded prescription medication that is not FDA-approved as a finished product. I understand that individual results vary, that topical absorption may differ based on skin condition and application site, and that the prescribing clinician retains full discretion over whether this product is appropriate for me. I acknowledge and agree.
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