Anti- Fungal Miconazole Nitrate Powder
FDA Label NDC 56104-253

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America Inc. for the product Anti- Fungal Miconazole Nitrate (NDC 56104-253). 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, do not use, when using this product, stop 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

for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Do Not Use

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

When Using This Product

avoid contact with the eyes.

Stop And Ask A Doctor If

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep Out Of Reach Of Children.

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

Directions

  • clean the affected area & dry thoroughly
  • apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

  • store between 59° - 86°F
  • lightly shake bottle to loosen settled powder

Inactive Ingredient

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Questions?

call 1-866-964-0939

Principal Display Panel

CORE VALUES

Absorbs Moisture

Miconazorb AF

ANTI-FUNGAL POWDER

Miconazole Nitrate 2%

Cures Most:

  • Athlete's foot
  • Jock itch
  • Ringworm

    • Relieves itching, burning, scaling and chafing

    Talc-Free

    NET WT 2.5 OZ (71 g)

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