Miconazole Nitrate Aerosol, Spray
FDA Label NDC 49035-135

14 label sections · Submitted to the FDA by Wal-mart Stores, Inc. · 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, extremely flammable:, do not use, when using this product, stop use and ask a doctor if, 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.

Extremely Flammable:

Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not sore at temperature above 120°F.

Do Not Use

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

When Using This Product

  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 2 weeks

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 persists, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store between 20 oC and 30 oC (68 o and 86 oF)
  • if nozzle clogs, clean with a pin

Inactive Ingredient

ISOBUTANE, SD ALCOHOL 40-B, KAOLIN, ZEA MAYS (CORN) STARCH, DISTEARDIMONIUM HECTORITE

Questions?

1-888-287-1915

Principal Display Panel

equate

ANTIFUNGAL POWDER SPRAY

Jock Itch

Miconazole Nitrate 2% /

Antifungal

  • Cures most jock itch
  • Relieves itching,

    • chafing & burning

    • Comforts & refreshes
    • Talc-free

      • NET WT. 4.6 OZ. (130 g)

* Please review the disclaimer below.