Miconazole Nitrate Aerosol, Spray
FDA Label NDC 49035-135

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Miconazole Nitrate (NDC 49035-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, flammable:, when using this product, stop use and ask a doctor if, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most jock itch (tinea cruris)
  • relieves itching, burning and chafing associated with jock itch

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.

When Using This Product

  • do not get into eyes or mouth
  • use only as directed. 

Stop Use And Ask A Doctor If

  • irritation occurs
  • no improvement within 2 weeks for jock itch

Do Not Use

on children under 2 years of age unless directed by a doctor. 

Keep Out Of Reach Of Children.

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

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • use daily for 2 weeks. If conditions persist, consult a doctor
  • this product is not effective on scalp or nails
  • if nozzle clogs, clean with a pin

Other Information

Store between 20oC and 30oC (68o and 86oF)

Inactive Ingredient

Disteardimonium Hectorite, Isobutane, Kaolin, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

Call 1-888-287-1915

Principal Display Panel

equate

Jock Itch

Powder Spray

Miconazole Nitrate 2%

Antifungal

Cures Most Jock Itch 

  • Talc- free
  • Relieves itching, chafing and burning

    • NET ET 4.6 OZ (130 g)

* Please review the disclaimer below.