All Purpose Nipple Ointment (APNO)

Anhydrous Base

A compounded ointment combining an antibacterial, a corticosteroid, and an antifungal, prepared to a prescriber's order for sore, damaged nipples.

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 All Purpose Nipple Ointment (APNO)
Dosage form	Ointment
Route	Topical
Active ingredients	Mupirocin, Betamethasone valerate, Miconazole
Technology	Anhydrous Base
Strengths in literature	Mupirocin 1%, betamethasone 0.05%, miconazole 2% in the published randomized trial
Commercial product	No U.S. commercial product
Strength and directions	Per prescriber
Dispensing	Valid prescription

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

Clinical Advantages

Multiple actives in one base
Custom strength available
Dye free option
Applied topically
No U.S. commercial equivalent

How It Works

What is All Purpose Nipple Ointment?

All Purpose Nipple Ointment, often shortened to APNO, is a compounded topical preparation that combines three medicines in one ointment base. Prescribers order it for lactating patients with sore or damaged nipples, and a pharmacy prepares it to the prescription.

How it works

Mupirocin is a topical antibacterial that acts on bacteria on the skin surface [3].
Betamethasone valerate is a topical corticosteroid that acts on inflammation where it is applied [1].
Miconazole is a topical antifungal, included because Candida is sometimes suspected in persistent nipple pain [4].
The ointment base holds the three actives in a water free vehicle that stays on the skin.

When prescribers choose it

Lactation medicine physicians and breastfeeding medicine clinics managing persistent nipple pain
OB GYN practices and midwives seeing patients in the early postpartum weeks
Family medicine and pediatric practices that follow the nursing dyad
Prescribers who want all three actives in one container rather than three separate products

Clinical Details

What does the evidence show?

Dennis and colleagues (2012, Breastfeeding Medicine) ran a double blind randomized trial in 151 breastfeeding women with nipple damage, comparing an all purpose nipple ointment with lanolin. There were no significant differences in mean pain scores one week after randomization [1].
A Cochrane review of treatments for painful nipples (Dennis and colleagues, 2014) included four trials and 656 women, among them the all purpose nipple ointment trial, and found insufficient evidence to recommend any specific treatment [2].
The same review reported that regardless of treatment used, nipple pain fell to mild levels for most women about 7 to 10 days after birth [2].
LactMed notes a small randomized trial in which mupirocin 2% applied after feedings was less effective than an oral antibiotic for sore, cracked nipples, at 16% versus 79% resolution [3].
The Academy of Breastfeeding Medicine defines persistent pain as breastfeeding associated pain lasting longer than two weeks and calls for evaluation of the mother and infant pair by a lactation specialist [4].

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 U.S. commercial product combines these three actives. Mupirocin ointment, betamethasone valerate ointment, and miconazole are each sold separately, so a prescriber who wants them in one ointment orders it from a compounding pharmacy.

Dosage forms and strengths

Strength of each active set by the prescriber
Antifungal component specified by the prescriber, such as miconazole, clotrimazole, or nystatin
Two active versions when the prescriber omits the antifungal
Dye free and fragrance free by request

The published trial used mupirocin 1%, betamethasone 0.05%, and miconazole 2% [1]. Application frequency, quantity, and duration are the prescriber's decision, and the Academy of Breastfeeding Medicine advises evaluation of the nursing pair when pain lasts beyond two weeks [4].

How Mixwell prepares it

Mixwell compounds this ointment in Chino, California under USP 795 standards for non sterile preparations [5]. The prescription should state each active, its strength, the quantity, and the directions, and our pharmacist confirms the antifungal choice before compounding. Batch records document each preparation, and finished ointments ship across California.

Safety information

This preparation is applied to skin an infant feeds from, so prescribers counsel on how much to use and whether to remove it before a feeding. LactMed reports that mupirocin is poorly absorbed after topical use and that little reaches the infant [3].

Topical corticosteroids carry a risk of skin thinning with prolonged use, and absorption rises with larger areas, longer courses, and occlusion. Prolonged mupirocin use may allow overgrowth of organisms that do not respond to it [3].

Pain that lasts beyond two weeks warrants evaluation of latch, positioning, and other causes rather than indefinite topical treatment [4]. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References

Dennis CL, Schottle N, Hodnett E, McQueen K. An all purpose nipple ointment versus lanolin in treating painful damaged nipples in breastfeeding women: a randomized controlled trial. Breastfeed Med. 2012;7(6):473 to 479. doi:10.1089/bfm.2011.0121
Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014;(12):CD007366. doi:10.1002/14651858.CD007366.pub2
Mupirocin. Drugs and Lactation Database (LactMed). National Institute of Child Health and Human Development, NCBI Bookshelf. LactMed record
Berens P, Eglash A, Malloy M, Stuebe AM. ABM Clinical Protocol #26: Persistent pain with breastfeeding. Breastfeed Med. 2016;11(2):46 to 53. doi:10.1089/bfm.2016.29002.pjb
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.

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Ontario
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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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