Lotrimin Af
FDA Label NDC 11523-4327

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 Af (NDC 11523-4327). 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, flammable, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Active Ingredient

(To Deliver) 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)
  • for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

Flammable

Do not use while smoking or near heat or flame

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

Otc - Stop Use

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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 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
  • 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 condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

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

Inactive Ingredients

dimethyl ether, polyoxyl 15 hydroxystearate, sd alcohol 40-B (16.5% v/v)

Questions?

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