Drugplain

4oz 1.2 g/120g

miconazole · SOAP · Nabrace LLC

10 Recalls on Record
Plain English

4oz is a soap containing miconazole at 1.2 g/120g, taken topical. Manufactured by Nabrace LLC.

Key Facts

Brand Name
4oz
Generic Name
miconazole
NDC Code (Product)
84056-003
Manufacturer
Nabrace LLC
Strength
1.2 g/120g
Dosage Form
SOAP
Route
TOPICAL
Marketing Status
Application #
M005
Drug Class
Azole Antifungal [EPC]
Marketing Start
02/01/2020

Recall History

10 Recalls on Record
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class II01/08/2016

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

TerminatedVoluntary: Firm initiated
Class I11/23/2021

The Procter & Gamble Company

Chemical contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class II04/17/2024

ARG Laboratories, Inc.

Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

OngoingVoluntary: Firm initiated
Class II02/18/2026

HTO Nevada Inc. dba Kirkman

Stability Data Does Not Support Expiry Date.

OngoingVoluntary: Firm initiated
Class II06/10/2019

Preferred Pharmaceuticals, Inc

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II11/23/2021

The Procter & Gamble Company

CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

TerminatedVoluntary: Firm initiated
Class III03/18/2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II06/20/2024

Little Moon Essentials LLC

CGMP deviations

OngoingVoluntary: Firm initiated
Class II07/13/2012

Island Kinetics dba Covalence

Microbial Contamination of Non Sterile Product; mold

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use9,276 reports
drug ineffective7,522 reports
fatigue5,830 reports
condition aggravated5,413 reports
nausea4,951 reports
rash4,847 reports
diarrhoea4,462 reports
pain4,433 reports
headache4,382 reports
dyspnoea4,258 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Use on chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation. for the temporary relief of pain associated with minor skin irritation

Dosage & Administration

Directions see important warnings under "When using thi sproduct" adults and children 2 years older: rub a thicj layer on chest & throat or rub on sore aching muscles cover with a warm, dry cloth if desired keep clothing loose about throat/ chest to help vapors reach the nose/mouth repeat up to three times per 24 hours or as directed by doctor children under 2 years: do not use

Warnings

Warnings For external use only; avoid contact with eyes. Do not use Do not use by mouth/in nostrils/ on wounds or damaged skin/ with tight bandages Ask a doctor before use if you have Ask a doctor before use if you have cough that occurs that too much phlegm(mucus) persistent ot chronic cough such as occurs with smoking, asthma or emphysema When using this product When using this product, do not heat microwave add to hot water or any container where heating water. May cause splattering and result in burns. Stop use and ask a doctor Stop use and ask a doctor if muscle aches and pains persist more than 7 days or come back cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is 4oz used for?

4oz contains miconazole. It is a soap taken topical. Consult your doctor for specific uses.

Is 4oz a controlled substance?

4oz is not classified as a controlled substance by the DEA.

What is the generic name for 4oz?

The generic name for 4oz is miconazole. There are 12 other brand versions of miconazole.

What is the NDC code for 4oz 1.2 g/120g?

The NDC (National Drug Code) for 4oz 1.2 g/120g is 84056-003, listed by Nabrace LLC.