Lotrimin
FDA Label NDC 11523-4140

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Lotrimin (NDC 11523-4140). 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, when using this product, stop use and ask a doctor if, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • proven clinically effective in the treatment of most jock itch (tinea cruris)
  • for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

When Using This Product

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 2 weeks

Otc - Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
  • in case of clogging, clean nozzle with a pin

Other Information

store between 20° to 25°C (68° to 77°F)

Questions?

1-866-360-3266

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