Miconazole Nitrate Cream
FDA Label NDC 50090-5607

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Miconazole Nitrate (NDC 50090-5607). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

Active Ingredient

Miconazole nitrate USP, 2%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort

Warnings

For external use only

Otc - Do Not Use

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

Otc - When Using

When using this product, avoid contact with the eyes.

Stop Use And Ask A Doctor If

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: pay special attention to the 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 condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other Information

  • do not use if foil seal on tube opening is broken or missing
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 15°-30°C (59°-86°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

How Supplied

Product: 50090-5607

NDC: 50090-5607-0 14 g in a TUBE / 1 in a CARTON

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