Miconazole Nitrate Aerosol, Spray
FDA Label NDC 69256-038

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter, Llc for the product Miconazole Nitrate (NDC 69256-038). 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, keep out of reach of children., 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 symptoms of jock itch including 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.

When Using This Product

  • do not get into eyes or mouth
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age. Do not use for diaper rash. Do not use on children under 2 years of age unless directed by a doctor.

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • 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
  • in case of clogging, clear nozzle under running water

Inactive Ingredient

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

Questions?

Call 1-866-964-0939

Principal Display Panel

Harris Teeter

Antifungal

Jock Itch

Powder Spray

MICONAZOLE NITRATE 2%

Cures Most Jock Itch

Relieves Itching, Chafing & Burning

Talc-Free

NET WT 4.6 OZ (130 g)

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