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medicated

miconazole · medicated is an azole antifungal (over-the-counter) containing miconazole, made by Nabrace LLC.

Type
Over the counter
Drug class
Azole Antifungal
Route
Topical
Manufacturers
1

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Drug facts

Generic name
miconazole
Active ingredients
Miconazole
Drug class
Azole Antifungal
Dosage forms
Soap
Label holder
Nabrace LLC
FDA application
M005
Label updated
04/16/2026

Active ingredients

(s) Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

In children less than 2 months of age on open skin wounds

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor

Irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, lavender oil, carbomer, purified water USP

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Soap1.7 g/170gtopical1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 2,414 reports that list miconazole, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug interaction238
  • Drug ineffective135
  • Diarrhea129
  • International normalised ratio increased127
  • Nausea109
  • Dyspnea90
  • Off label use90
  • Rash87
  • Urinary tract infection86
  • Fatigue77

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • Nabrace LLCShown hereM005 · Label 04/16/2026 · NDC 84056-002Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

medicated: common questions

What is medicated used for?
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
Is medicated a prescription drug?
No. medicated is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as medicated?
Yes. Other FDA-listed products with the same active ingredients include natouch, Antifungal, 4oz, Oravig.
Who makes medicated?
Nabrace LLC lists medicated with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/16/2026 · Label text is shown as published by the manufacturer. Not medical advice