Lotrimin
FDA Label NDC 11523-1272

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 11523-1272). 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 - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Flammable

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Questions?

→ Inactive Ingredients

→ Principal Display Panel - 133 G Can Label

Other

Drug Facts

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
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 - When Using

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.

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
in case of clogging, clean nozzle with a pin