Baclofen 2% | Bupivicaine 1% | Cyclobenzaprine 2% | Diclofenac 3% | Gabapentin 6%

Applied topically to the specific area of pain per prescriber direction:

• Apply a prescribed amount of gel or cream to the intact skin over the area of pain or muscle spasm.
• Rub gently until absorbed; do not apply to broken, infected, or abraded skin.
• Wash hands immediately after application to prevent inadvertent systemic absorption and transfer.
• Avoid contact with eyes, mucous membranes, and open wounds.
• Cover the area with clothing or an occlusive dressing only if specifically directed by the prescriber, as occlusion may significantly increase systemic absorption.
• Application is typically 2–4 times daily to the site of localized pain, as directed; frequency is prescriber-determined.

All dosing parameters — including amount applied per application, frequency, and duration — are prescriber-determined based on the patient's pain type, location, and response. Key considerations:

• Topical compounded pain preparations are applied locally to minimize systemic exposure compared to oral routes; systemic bioavailability is generally low but variable by compound and application site.
• The prescriber may specify the number of pumps or measured volume to apply per dose.
• Duration of use should be periodically reassessed by the prescriber; these preparations are not intended for indefinite unsupervised use.
• Patients should notify the prescriber if they experience systemic symptoms (dizziness, drowsiness, cardiovascular effects) suggesting unexpected systemic absorption.

• Baclofen: Agonizes GABA-B receptors in peripheral nociceptive afferents and potentially at dorsal horn-level through transdermal CNS exposure; reduces hyperalgesia and allodynia by hyperpolarizing sensory neurons and inhibiting excitatory neurotransmitter release.
• Bupivacaine: Blocks voltage-gated sodium channels (Nav1.7, Nav1.8) in peripheral sensory neurons in a concentration- and use-dependent manner, preventing action potential generation and conduction along C-fibers and A-delta fibers responsible for pain transmission.
• Cyclobenzaprine: Acts on brainstem and spinal cord (in systemic use) and peripherally on muscle spindle efferents; reduces tonic somatic motor activity and may attenuate peripheral sensitization contributing to myofascial pain at topical application sites.
• Diclofenac: Inhibits cyclooxygenase-1 and COX-2, reducing the conversion of arachidonic acid to prostaglandins (particularly PGE2) locally; prostaglandins sensitize peripheral nociceptors to mechanical and chemical stimuli — their reduction lowers pain threshold at the application site. Diclofenac also may directly inhibit the arachidonic acid cascade and has sodium channel-blocking properties.
• Gabapentin: Binds the alpha-2-delta-1 subunit of voltage-gated calcium channels at presynaptic terminals of primary afferent neurons, reducing calcium influx and decreasing release of excitatory neurotransmitters (glutamate, substance P) that drive central sensitization and neuropathic pain.

This compounded topical formulation is prescribed for prescriber-directed management of localized neuropathic pain, myofascial pain, musculoskeletal pain, fibromyalgia, and conditions requiring multi-mechanism analgesic therapy including neuropathic and inflammatory components (e.g., complex regional pain syndrome, post-herpetic neuralgia, diabetic neuropathy, osteoarthritis of superficial joints). Clinical considerations for prescribers:

• Topical delivery limits systemic exposure compared to oral formulations, potentially improving tolerability in patients sensitive to systemic side effects of individual agents (e.g., oral gabapentin sedation, oral diclofenac GI effects).
• Evidence for compounded topical analgesic combinations is limited; a Johns Hopkins RCT (2019) found only modest effects for compounded topical pain preparations vs. placebo in a heterogeneous pain population. Prescribers should weigh the available evidence and frame treatment in a shared decision-making context.
• Diclofenac sodium 1% gel (Voltaren) is the only FDA-approved topical NSAID for osteoarthritis; the 3% compounded concentration is a prescriber-directed modification.
• Gabapentin topical use for neuropathic pain is off-label; evidence for transdermal delivery of gabapentin achieving clinically meaningful local tissue concentrations remains under investigation.
• Monitor for signs of systemic absorption, particularly from bupivacaine (cardiovascular) and cyclobenzaprine (anticholinergic).

Contraindications:

• Hypersensitivity to any component: amide local anesthetics (bupivacaine), NSAIDs (diclofenac), or any other listed ingredient.
• Known allergy to NSAID drugs; caution with aspirin-sensitive asthma (diclofenac cross-reactivity).
• Do not apply to broken, infected, or ulcerated skin.
• Do not apply near eyes or on mucous membranes.

Warnings & Precautions:

• Bupivacaine: rare but serious risk of cardiac arrhythmia and CNS toxicity if absorbed systemically in excess (avoid prolonged large-area occlusive application).
• Diclofenac: topical NSAIDs carry a boxed warning risk of cardiovascular thrombotic events and GI bleeding if significant systemic absorption occurs; use caution in patients with cardiovascular disease, renal impairment, or GI ulcer history.
• Cyclobenzaprine: may have additive CNS depression effects if systemically absorbed alongside other CNS depressants or alcohol.
• Gabapentin: dizziness or somnolence if systemic levels are unexpectedly achieved.
• Wash hands thoroughly after application to avoid inadvertent systemic or ocular exposure.

Drug Interactions:

• Cyclobenzaprine with MAOIs: avoid concurrent use (risk of hyperpyrexia, seizures).
• Diclofenac with anticoagulants (warfarin): even topical NSAIDs may increase bleeding risk in sensitive patients.
• Bupivacaine with other local anesthetics or antiarrhythmics (e.g., mexiletine): additive cardiac channel blockade risk.

Common Side Effects: Local skin reactions including erythema, burning sensation, pruritus, and contact dermatitis at the application site; skin dryness or scaling; transient paresthesia from bupivacaine.

Store at controlled room temperature (15–25°C / 59–77°F) in a tight container away from heat, direct sunlight, and moisture. Do not freeze. Keep out of reach of children and pets. Use by the beyond-use date (BUD) assigned per USP <795> compounding guidelines. Discard if the preparation separates, changes color, or develops an unusual odor.

Is this topical cream FDA-approved?

No. This is a patient-specific, prescriber-directed 503A compounded preparation from Genesis Compounding. While individual ingredients (diclofenac topical, bupivacaine injectable, gabapentin oral) have FDA-approved formulations for various indications, this specific five-ingredient combination topical preparation is not FDA-approved.

Why are so many ingredients combined in one cream?

Pain conditions involving neuropathic, inflammatory, and myospastic components may benefit from simultaneous blockade of multiple pain pathways. Each ingredient in this formulation targets a different mechanism — local anesthesia, COX inhibition, GABA-mediated muscle relaxation, calcium channel modulation, and antispasmodic activity — allowing prescriber-tailored multi-mechanism analgesia in a single topical application.

Will I experience systemic side effects from a topical cream?

Topical application generally produces lower systemic exposure than oral dosing. However, systemic absorption can occur, particularly with large application areas, prolonged use, broken skin, or occlusion. Contact your prescriber if you experience dizziness, drowsiness, palpitations, or other systemic effects.

How long and how often should I apply this?

Frequency and duration are determined by your prescriber based on your specific condition and response. Apply only the prescribed amount to the designated area; do not increase dose or frequency without prescriber guidance.

What is the evidence for compounded topical pain creams?

Clinical evidence for multi-ingredient compounded topical analgesics is limited and mixed. Some patients report meaningful pain relief, while controlled studies have found modest effects compared to placebo. Your prescriber will integrate this formulation into an individualized pain management plan and reassess response at follow-up visits.