# US 12,594,260 B2 · Topical formulations for infections

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- Number: US 12,594,260 B2
- Document ID: US12594260B2
- Status: Granted
- Kind: B2
- Application number: 18/759,222
- Filed: 2024-06-28
- Published: 2026-01-01
- Granted: 2026-04-07
- Earliest claimed: 2024-06-28
- Assignees: Topical Rx, LLC
- Applicants: Topical Rx, LLC
- Inventors: David A. Stoller
- Web page: https://patentgrep.com/patent/US12594260B2

## CPC

- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 31/4174: Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/351: not condensed with another ring
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 31/10: Antimycotics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Described herein are topical compositions containing one or more of an antibacterial, an antifungal, and an anti-inflammatory, for use in supporting the health of a subject, including preventing or treating a fungal infection, a yeast infection, a bacterial infection, inflammation, or any combination thereof.

## Claims

### Claim 1

A composition formulated for topical use comprising active ingredients and one or more excipients, wherein the active ingredients consist of mupirocin, or a pharmaceutically acceptable salt thereof, in an amount of between about 0.2 and about 0.75% v/v, terbinafine, or a pharmaceutically acceptable salt thereof, in an amount between about 0.1 and about 0.5% v/v, clotrimazole, or a pharmaceutically acceptable salt thereof, in an amount between about 0.1 and about 0.5% v/v, and hydrocortisone, or a pharmaceutically acceptable salt thereof, in an amount between about 0.1 and about 0.5% v/v.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the active ingredients consist of about 0.5% v/v of the mupirocin, or the pharmaceutically acceptable salt thereof, about 0.25% v/v of the terbinafine, or the pharmaceutically acceptable salt thereof, about 0.25% v/v of the clotrimazole, or the pharmaceutically acceptable salt thereof, and about 0.25% v/v of the hydrocortisone, or the pharmaceutically acceptable salt thereof.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition is in the form of a cream, an ointment, a lotion, or a gel.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the mupirocin, or the pharmaceutically acceptable salt thereof, in an amount of about 0.5% v/v.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the clotrimazole, or the pharmaceutically acceptable salt thereof, in an amount of about 0.25% v/v.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the terbinafine, or the pharmaceutically acceptable salt thereof, in an amount of about 0.25% v/v.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the hydrocortisone, or the pharmaceutically acceptable salt thereof, in an amount of about 0.25% v/v.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the one or more excipients is selected from purified water, ethyl alcohol, benzyl alcohol, cetyl alcohol, stearyl alcohol, cetostearyl alcohol, cetyl alcohol, octyldodecanol, cetyl palmitate, isopropyl myristate, polysorbate 60, sodium hydroxide, sodium monostearate, glyceryl monostearate, corn oil, chamomile flower oil, mineral oil, paraffin, petrolatum, maltodextrin, phenoxyethanol, polyoxyl 20 cetostearyl ether, xanthan gum, methylparaben, propylene glycol, propylparaben, sodium lauryl sulfate, sodium cetostearyl sulfate, aloe vera gel, glycerin, citric acid, vitamin A palmitate, cholecalciferol, or alpha-tocopherol acetate.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the active ingredients consist of mupirocin calcium in an amount of about 0.5% v/v, terbinafine hydrochloride in an amount of about 0.25% v/v, clotrimazole in an amount of about 0.25% v/v, and hydrocortisone acetate in an amount of about 0.25% v/v.

### Claim 10 (depends on 1)

A method of treating a rash, jock itch, Athlete's foot, or fungal toenails, the method comprising topically administering to a subject the composition of claim 1.

### Claim 11 (depends on 10)

The method of claim 10, wherein the method treats athlete's foot, or jock itch.

### Claim 12 (depends on 11)

The method of claim 11, wherein the method treats athlete's foot.

### Claim 13 (depends on 10)

The method of claim 10, wherein the method comprises administering the composition once daily, twice daily, or three times daily.

### Claim 14 (depends on 10)

The method of claim 10, wherein the administration is performed for a duration of from about 1 day to about 4 weeks.