TopicalTopicalNon sterile Rx only

Low Dose Naltrexone (LDN) Compounded Topical Cream

Anhydrous Topical Formulation

Low dose naltrexone (LDN) compounded as a topical in PermE8 with WO6 anhydrous bases. FDA labels naltrexone only as an oral 50 mg tablet. Chino, CA.

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 Low Dose Naltrexone (LDN) Compounded Topical Cream
Dosage form	Topical
Route	Topical
Active ingredients	Naltrexone hydrochloride
Technology	Anhydrous Topical Formulation
Strengths in literature	Tablets: 50 mg, oral (FDA label). No FDA labeled topical strength.
Commercial product	Commercial product in a different dosage form
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

Strength set by the prescriber
Anhydrous PermE8 with WO6 base
Topical form instead of a swallowed dose
Longer default beyond use date than water based creams
Non sterile preparation

How It Works

What is low dose naltrexone (LDN)?

Naltrexone is an opioid antagonist, which means it blocks opioid receptors. The FDA approved naltrexone hydrochloride as a 50 mg oral tablet. The label lists treatment of alcohol dependence and blockade of the effects of opioids given from outside the body [1].

Low dose naltrexone, or LDN, is the name used for naltrexone prepared at strengths below the 50 mg tablet. No FDA label describes a low dose strength, a topical form, or an LDN use. LDN topicals are not FDA approved.

What is a compounded topical?

A topical is a cream or gel applied to the skin. The medicine is mixed evenly through a base. A compounding pharmacy makes it to the prescriber's order, so the strength is not limited to the 50 mg tablet.

What are PermE8 and WO6?

PermE8 Anhydrous Gel and WO6 Anhydrous Topical Gel are two PCCA bases. Their manufacturer lists both as white to off-white cream-gels with a water activity below 0.6, which it classifies as anhydrous [2][3]. The manufacturer lists PermE8 as able to hold multiple drugs, including salt forms [2]. It states WO6 should only be used for topical applications [3]. These are the manufacturer's descriptions.

What compounding in PermE8 with WO6 provides

A strength set by the prescriber, which no commercial naltrexone product offers in a topical
Two bases that are both listed as anhydrous, so the finished topical has no added water
A base that can hold a drug in its salt form, as naltrexone hydrochloride is [2]
A USP 795 default beyond use date of up to 180 days for a nonaqueous preparation, longer than a water based cream [4]

FDA labeling does not describe how naltrexone is absorbed through skin or how a topical compares with a swallowed tablet.

For prescribers

Family medicine, internal medicine, pain management, rheumatology, dermatology, neurology, and functional or integrative medicine prescribers (MD, DO, NP, PA, ND) who want a topical strength the 50 mg tablet does not offer
Send the prescription with the strength, the amount, and the application site. Call (909) 378-7301 to speak with our pharmacist
Review the label contraindications, including opioid analgesics, before prescribing [1]

For patients

Your prescriber decides if this is right for you and tells you where and how much to apply
Use it only on skin, never on the inside of the mouth, vagina, or rectum
Tell your prescriber about every opioid pain medicine you take, including some cough and diarrhea medicines

Clinical Details

What does the evidence show?

The FDA approved naltrexone hydrochloride 50 mg oral tablets for alcohol dependence and for blockade of the effects of opioids given from outside the body [1].
The label states naltrexone has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions [1].
No FDA label describes a low dose strength or a topical form, and 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

Naltrexone is FDA approved as a 50 mg oral tablet [1]. No approved product is a topical or comes in a lower strength. A prescriber who wants a topical form orders it compounded.

Dosage forms and strengths

Strength set by the prescriber
PermE8 with WO6 anhydrous base
Quantities matched to the prescription

Dosing is the prescriber's decision.

Frequently asked questions about the base

Why is PermE8 with WO6 the recommended base?

Mixwell recommends this pair of PCCA bases for LDN topicals. Both are listed by their manufacturer as anhydrous, with a water activity below 0.6, so the finished topical has no added water [2][3].

What does an anhydrous base mean for the beyond use date?

USP 795 gives nonaqueous preparations a default beyond use date of up to 180 days, longer than the 35 days for a preserved water based cream [4]. The pharmacist assigns the date for each preparation.

Can the base hold naltrexone hydrochloride?

The manufacturer lists PermE8 as able to hold multiple drugs at once, including salt forms [2]. Naltrexone hydrochloride is a salt form.

What does PermE8 add?

The manufacturer lists PermE8 as penetration enhancing, based on an in vitro test of ketoprofen through human skin tissue [2]. That test did not use naltrexone, and no data show how naltrexone behaves in this base.

What does WO6 add?

The manufacturer lists WO6 as a cream-gel with a viscosity range of 72,000 to 198,000 cP and states it is safe for topical use [3]. It lists PermE8 at 48,000 to 130,000 cP [2]. The manufacturer states WO6 should be used only on skin [3].

Is there manufacturer data on mixing the two bases?

No. The manufacturer pages for PermE8 and WO6 do not describe a combination or a ratio. The pharmacist and prescriber confirm the final formula.

How Mixwell prepares it

Mixwell compounds this topical in Chino, California under USP 795 standards for non sterile preparations [4]. Our pharmacist confirms the strength with the prescriber and assigns the beyond use date. Finished topicals ship across California, including Chino Hills, Ontario, Pomona, Diamond Bar, and Rancho Cucamonga.

Safety information

Naltrexone labeling lists these contraindications: taking opioid analgesics, current opioid dependence including methadone or buprenorphine, acute opioid withdrawal, a failed naloxone challenge or positive opioid urine screen, and hypersensitivity [1].

The label warns of liver injury, of precipitated opioid withdrawal that can need hospital care, and of fatal overdose if a patient takes opioids at prior doses after treatment lowers tolerance. It reports depression and suicidal thoughts in postmarketing use [1].

These warnings come from the oral 50 mg tablet label. No FDA labeling describes topical use, low dose strengths, or how much naltrexone enters the body through skin. Patient selection, dosing, and monitoring are the prescriber's responsibility. Patients should talk with their own healthcare professional before using any medication.

References

Naltrexone hydrochloride tablets USP, 50 mg. Prescribing information. DailyMed
PCCA. PermE8 Anhydrous Gel (30-5038), manufacturer description. Used only to describe the base, not as evidence for any clinical claim.
PCCA. WO6 Anhydrous Topical Gel (30-5039), manufacturer description. Used only to describe the base, not as evidence for any clinical claim.
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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