Miconazole Nitrate
FDA Label NDC 42254-319

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Miconazole Nitrate (NDC 42254-319). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, 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

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning and discomfort associated with those conditions

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 Use And Ask A Doctor If

  • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
  • irritation occurs or if there is 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.

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the 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:

    • use daily for 4 weeks. If condition persists longer, consult a doctor.
    • pay special attention to the spaces between the toes
    • wear well-fitting, ventilated shoes
    • change shoes and socks at least once daily

      • For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

      For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

      This product is not effective on the scalp or nails.

Other Information

  • store at 15° - 30°C (59° - 86°F)
  • lot number and expiration date: see crimp of tube or see box
  • to open: unscrew cap, use pointed end on cap to puncture seal

    • You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Other

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 10/09 R2
8280719 7805

Repackaged by
Rebel Distributors Corp.
Thousand Oaks, CA 91320

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