GelTopicalNon sterile Rx only

Doxycycline 1% Topical

Anhydrous Gel Bases (PermE8®, WO6®)

A compounded doxycycline 1% gel in PCCA's PermE8 or WO6 anhydrous 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 Doxycycline 1% Topical
Dosage form	Gel
Route	Topical
Active ingredients	Doxycycline
Technology	Anhydrous Gel Bases (PermE8®, WO6®)
Strengths in literature	FDA approved doxycycline for rosacea is a 40 mg oral capsule
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

Custom strength available
Water free gel base
Applied topically
Non sterile preparation

How It Works

What is doxycycline?

Doxycycline is a tetracycline class drug. The FDA approved Oracea, a doxycycline 40 mg capsule taken by mouth, for only the inflammatory lesions (papules and pustules) of rosacea in adults [1][2].
The label says the capsule was not evaluated for the redness, visible small blood vessels, or eye parts of rosacea, and that it does not lessen redness [1].

No topical doxycycline product is listed among the labels cited here. The approved capsule is taken by mouth.

What compounding in PermE8 or WO6 provides

PermE8 and WO6 are anhydrous (water free) gel bases made by PCCA. Mixwell prepares doxycycline 1% topical gel in either base at the strength the prescriber orders. PCCA's base pages do not name doxycycline for either base. PCCA describes them as follows:

PermE8 Anhydrous Gel [3]

Water activity below 0.6, which PCCA ties to a longer beyond use date and fewer refills
Designed to enhance permeation of the drug
Holds multiple drugs, including salt forms
Not tacky or oily

WO6 Anhydrous Topical Gel [4]

Water activity below 0.6, with a longer default beyond use date
Smooth and creamy, not greasy or tacky
Emollient feel on the skin
Accommodates drugs with poor stability in water

These are the manufacturer's descriptions of its bases. They are not findings by the FDA, and they are not claims about doxycycline.

When prescribers choose it

Dermatologists and primary care providers managing rosacea
Prescribers who want a topical doxycycline strength they set themselves
Prescribers who prefer a water free gel base

Clinical Details

What does the evidence show?

FDA approved doxycycline for rosacea is a 40 mg capsule taken by mouth, labeled for only the inflammatory lesions of rosacea in adults [1][2].
The label states it does not lessen the redness of rosacea [1].
No topical doxycycline gel is among the labels cited here. PCCA does not name doxycycline for PermE8 or WO6 [3][4]. 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

The FDA approved doxycycline for rosacea as a 40 mg capsule taken by mouth [1][2]. A prescriber who wants a topical doxycycline gel, at a strength they set, orders it compounded.

Dosage forms and strengths

Strength set by the prescriber, such as 1%
PermE8 or WO6 anhydrous gel base
Quantities matched to the prescription

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

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

Safety information

Doxycycline labeling for the capsule warns that tetracycline class drugs can cause permanent yellow, gray, or brown tooth discoloration and slowed bone growth during tooth and bone development. The label says not to use it in pregnancy because it can cause fetal harm. It also warns of photosensitivity, so sun exposure should be limited [1][2].

The label contraindicates use in people with a history of hypersensitivity to doxycycline or other tetracyclines [1].

No FDA labeling states how much doxycycline is absorbed from a topical gel, or how either base affects skin irritation. Tell your prescriber about any allergies and about pregnancy. Mixwell can provide the ingredient list for your preparation. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References

Oracea (doxycycline) capsules. Prescribing information. DailyMed. DailyMed
Doxycycline capsules, 40 mg. Prescribing information. DailyMed. DailyMed
PermE8 Anhydrous Gel. Product information. PCCA. PCCA product page
WO6 Anhydrous Topical Gel. 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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