Mouth rinseOralNon sterile Rx only

Lidocaine HCl 2% Oral Rinse (MucoLox™)

Mucoadhesive Oral Base

A compounded lidocaine HCl 2% oral rinse in PCCA's MucoLox base, prepared in Chino, CA to a prescriber's order. Not FDA approved.

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 Lidocaine HCl 2% Oral Rinse (MucoLox™)
Dosage form	Mouth rinse
Route	Oral
Active ingredients	Lidocaine Hydrochloride
Technology	Mucoadhesive Oral Base
Strengths in literature	FDA approved lidocaine viscous is 2% (20 mg per mL)
Commercial product	Commercial product in a different dosage form
Strength and directions	Per prescriber
Dispensing	Valid prescription

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

Clinical Advantages

Coating base for mouth tissue
Custom strength available
Non sterile preparation

How It Works

What is lidocaine?

Lidocaine hydrochloride is an amide type local anesthetic. FDA approved lidocaine viscous 2% (20 mg per mL) is labeled for topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx [1].
The same label lists reducing gagging during X rays and dental impressions [1].

The FDA approved product is a viscous solution in a squeeze bottle. Its inactive ingredients include carboxymethylcellulose sodium, flavoring, methylparaben, propylparaben, purified water, and saccharin sodium [1].

What MucoLox is, and what compounding in it provides

MucoLox is a compounding base sold by PCCA. Mixwell prepares lidocaine HCl 2% as an oral rinse in MucoLox at the strength the prescriber orders. PCCA's base page does not name lidocaine. PCCA describes MucoLox as follows [2]:

A colorless, semi-translucent, viscous liquid, soluble in water, with a pH of 5 to 6
A polymer network that bonds to the mucosa and does not easily wash away, creating a lightweight coating
Improves contact time of the active ingredient on mucosal surfaces
Water soluble, for improved moisturization
Pleasant, neutral taste
Outstanding stability
Formulated without gluten, casein, dye, and parabens, among other allergens
Listed uses include oral rinse and mouthwash, oral moisturizer and protectant, and swish and spit formulas

The FDA labeled product contains methylparaben and propylparaben [1]. A MucoLox rinse lets a prescriber order lidocaine without those two preservatives, which matters for a patient with a paraben allergy. These are the manufacturer's descriptions of its base. They are not findings by the FDA, and they are not claims about lidocaine.

When prescribers choose it

Dentists and oral surgeons who want a lidocaine rinse in a paraben free, dye free base
Prescribers who want to set the strength and volume themselves
Prescribers whose patients react to an ingredient in the commercial viscous solution

Clinical Details

What does the evidence show?

FDA approved lidocaine viscous 2% is labeled for topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx [1].
The commercial product contains methylparaben and propylparaben. PCCA describes MucoLox as formulated without parabens [1][2].
No FDA approved product is made in MucoLox, which PCCA sells as a compounding base. The FDA has not reviewed this preparation [2].

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

FDA approved lidocaine viscous 2% is made with a set formula that includes parabens, flavoring, and saccharin [1]. A prescriber who wants the same strength in a different base, with no parabens or dye, orders it compounded.

Dosage forms and strengths

Lidocaine HCl 2% oral rinse, or another strength the prescriber sets
MucoLox base, a coating, water soluble vehicle
Volumes matched to the prescription

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this rinse in Chino, California under USP 795 standards for non sterile preparations [3]. Our pharmacist confirms the strength and base with the prescriber before compounding. Batch records document every preparation, and finished rinses ship across California.

Safety information

Lidocaine viscous labeling warns that cases of methemoglobinemia have been reported with local anesthetics. Risk is higher in people with G6PD deficiency, congenital or idiopathic methemoglobinemia, heart or lung problems, infants under 6 months, and those exposed to oxidizing agents. Signs can appear right away or hours later [1].

For children under 3, the label reports seizures, cardiopulmonary arrest, and death when the product was not used as directed. It says the product should generally not be used for teething pain [1].

The label warns that too much, or doses too close together, can cause high blood levels and serious reactions. These include dizziness, drowsiness, tremors, seizures, a slow heart rate, and low blood pressure. It contraindicates use with a known allergy to amide type local anesthetics or to other ingredients of the solution [1].

No FDA labeling covers this rinse. The label's dose limits come from the commercial product, and Mixwell does not set dosing. Tell your prescriber about every medicine you take and any allergies. Mixwell can provide the ingredient list for your preparation. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References

Lidocaine Viscous (lidocaine hydrochloride oral topical solution, USP), 2%. Prescribing information. DailyMed. DailyMed
MucoLox. Product information. PCCA. PCCA product page
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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