Antifungal Powder
FDA Label NDC 80513-771

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Antifungal (NDC 80513-771). 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, keep out of reach of children., directions, other information, inactive ingredients, 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 treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) 
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch 

Warnings

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes.

Stop and ask a doctor if

  • for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks
  • for jock itch - if irritation occurs, or if 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

  • clean the affected area and dry thoroughly
  • apply a thin layer of powder 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 20° to 25°C (68° to 77°F)
  • Protect from freezing. Avoid excessive heat.
  • Do not use if package is damaged.

Inactive Ingredients

allantoin, chloroxylenol, corn starch, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate.

Questions?

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