CreamTopicalNon sterile Rx only

Ketoprofen / Cyclobenzaprine / Lidocaine Topical

Transdermal Cream Base (Lipoderm®)

A compounded cream with ketoprofen, cyclobenzaprine, and lidocaine in PCCA Lipoderm base, prepared in Chino, CA to a prescriber's order.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

USP <795> compliant
USP <800> hazardous drug lab
PCCA member

At a Glance

Preparation details for Ketoprofen / Cyclobenzaprine / Lidocaine Topical
Dosage form	Cream
Route	Topical
Active ingredients	Ketoprofen, Cyclobenzaprine, Lidocaine
Technology	Transdermal Cream Base (Lipoderm®)
Commercial product	No U.S. commercial product
Strength and directions	Per prescriber
Dispensing	Valid prescription

Speak with our pharmacist Send a prescription

Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Multiple actives in one base
Custom strength available
Applied topically
Non sterile preparation

How It Works

What is Ketoprofen / Cyclobenzaprine / Lidocaine Topical?

It is a compounded cream that combines three medicines in Lipoderm, a cream base made by PCCA. Ketoprofen is a nonsteroidal anti inflammatory drug (NSAID). Cyclobenzaprine is a muscle relaxant. Lidocaine is a local anesthetic. Mixwell prepares it in Chino, California by prescription, at the strengths the prescriber sets.

What compounding in Lipoderm provides

PCCA describes Lipoderm as a permeation enhancing cream base, designed for topical formulations that act locally or are absorbed through the skin. PCCA lists these features:

A smooth, thick cream
Physical stability: it does not separate with refrigeration
Use with more than one active ingredient, up to four at one time, so several medicines can be carried in one cream
It is the base named in the USP compounded preparation monograph for Ondansetron Compounded Topical Gel, 20 mg/mL

In practice, a Lipoderm cream lets a prescriber order three medicines as one product, at strengths no commercial topical offers, and apply them in a single step. These are the manufacturer's descriptions, not findings by the FDA.

When prescribers choose it

Pain management, sports medicine, and physical medicine practices
Prescribers who want several medicines in one topical cream
Prescribers whose patients cannot take these medicines by mouth

Clinical Details

What does the evidence show?

FDA approved ketoprofen is an oral capsule labeled for the management of pain and for primary dysmenorrhea [1].
FDA approved cyclobenzaprine is an oral tablet labeled as an adjunct to rest and physical therapy for muscle spasm with acute, painful musculoskeletal conditions, for up to two or three weeks [2].
FDA approved topical lidocaine includes a 5% patch labeled for pain from postherpetic neuralgia [3].
No FDA approved product contains all three ingredients, and none is approved as a cream with these ingredients. The FDA has not reviewed this preparation.

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

No commercial product combines these three ingredients in one topical. A prescriber who wants them together, or who wants a strength no approved product offers, orders the cream compounded.

Dosage forms and strengths

Strength of each ingredient set by the prescriber
Lipoderm cream base
Quantities matched to the prescribed course

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this cream in Chino, California under USP 795 standards for non sterile preparations [5]. Our pharmacist confirms the strengths and application directions with the prescriber before compounding. Batch records document every preparation, and finished creams ship across California.

Safety information

Oral ketoprofen carries a boxed warning for serious cardiovascular thrombotic events, including heart attack and stroke, and for serious gastrointestinal bleeding, ulceration, and perforation. Elderly patients are at greater risk. It is contraindicated around coronary artery bypass graft surgery [1].

Cyclobenzaprine labeling warns of serotonin syndrome with other serotonergic drugs and contraindicates use with MAO inhibitors [2]. Lidocaine patch labeling states that applying it to larger areas or for longer than directed can raise absorption and cause serious adverse effects, and that the amount absorbed from all lidocaine and other local anesthetic products must be counted [3].

These warnings come from labeling for oral or other approved forms. No FDA labeling states how much of each ingredient is absorbed from a compounded cream, so prescribers count the cream toward a patient's total exposure to each drug. Patient selection, dosing, and duration are the prescriber's responsibility.

References

Ketoprofen capsules, USP. Prescribing information. DailyMed. DailyMed
Cyclobenzaprine hydrochloride tablets, USP. Prescribing information. DailyMed. DailyMed
LIDODERM (lidocaine patch 5%). Prescribing information. U.S. Food and Drug Administration. FDA label
Lipoderm. Product information. PCCA. PCCA
United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

APIs and strengths
Base or vehicle
Quantity
Directions for use
Refills
Allergies or dye free needs

Call (909) 378-7301 Fax (909) 378-7071

Compounded in Chino, CA. Delivered across California.

Chino
Chino Hills
Ontario
Pomona
Diamond Bar
Rancho Cucamonga
Eastvale

Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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