Compounded | Low Risk

Topical Pain Compound (Diclofenac/Baclofen/Cyclobenzaprine)

What to know about Topical Pain Compound (Diclofenac/Baclofen/Cyclobenzaprine): uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.

Topical Pain Compound (Diclofenac/Baclofen/Cyclobenzaprine) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. Multi-ingredient topical for musculoskeletal pain.

Key Takeaways

  • TGA Schedule: S4 in Australia
  • Risk level: Low (1 points)

Scheduling and Classification

Jurisdiction Classification Status
Australia (TGA) S4 Not PBS listed

Risk Profile

Risk Level Low
Risk Points 1
CNS Depressant No
Respiratory Risk No

Multi-ingredient topical for musculoskeletal pain.

How Topical Pain Compound (Diclofenac/Baclofen/Cyclobenzaprine) is regulated

Topical Pain Compound (Diclofenac/Baclofen/Cyclobenzaprine) is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.

Australia TGA / PBS / State Schemes

Classified as S4 under the Therapeutic Goods Administration (TGA).

Clinical Evidence

  • Topical compounded analgesics for chronic pain — NEJM trial - Brutcher RE, et al. (2019)

    Large RCT in NEJM finding topical compounded analgesics (including gabapentin/ketamine combinations) were NOT superior to placebo for neuropathic pain.

    NEJM RCT — strongest evidence against these compounds. Key reference for R&N determinations.

  • SIRA: Compounded medication prior approval requirements - SIRA NSW (2023)

    Compounded medications typically require prior approval in NSW workers comp. SIRA notes limited evidence base for most compounded pain formulations.

    NSW workers comp regulator

Check this medication against your full medication list

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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.