Lotrimin ® - DailyMed Details

Lotrimin ®

SPL v9

SPL

SPL Set ID 67e2bbb3-69bf-4939-a3c3-66c0addec313

Route

TOPICAL

Published

Effective Date 2012-04-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Miconazole (20 mg)

Inactive Ingredients

Talc Isobutane

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 1993-09-01

Description

Drug Facts

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

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

Warnings

For external use only

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

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

Questions?

1-866-360-3266

Distribution

Distributed by Bayer HealthCare LLC, Whippany NJ 07981 USA

Active Ingredient

Miconazole nitrate 2%

Other Information

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

Inactive Ingredients

Inactive ingredients isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

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

Principal Display Panel 133 G Can Label

Powder Spray

goes on dry

NDC 11523-4140-2

LOTRIMIN ^® AF

ANTIFUNGAL

miconazole nitrate

Clinically Proven To Cure

Most Jock Itch

Relieves Itching,

Burning, Scaling

& Chafing

NET WT 133g (4.6 OZ)

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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

Purpose

Antifungal

Warnings

For external use only

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

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

Questions?

1-866-360-3266

Distribution

Distributed by Bayer HealthCare LLC, Whippany NJ 07981 USA

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Inactive ingredients isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

When Using This Product (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 (Stop use and ask a doctor if)

irritation occurs
there is no improvement within 2 weeks

Principal Display Panel 133 G Can Label (PRINCIPAL DISPLAY PANEL - 133 g Can Label)

Powder Spray

goes on dry

NDC 11523-4140-2

LOTRIMIN ^® AF

ANTIFUNGAL

miconazole nitrate

Clinically Proven To Cure

Most Jock Itch

Relieves Itching,

Burning, Scaling

& Chafing

NET WT 133g (4.6 OZ)

Advanced Ingredient Data

[{"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICONAZOLE", "unii": "7NNO0D7S5M", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ISOBUTANE", "unii": "BXR49TP611", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50570-1": "Do not use on children under 2 years of age except under the advice and supervision of a doctor.", "Purpose": "Antifungal", "Warnings": "For external use only Flammable: Do not use while smoking or near heat or flame", "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", "Questions?": "1-866-360-3266", "Distribution": "Distributed by Bayer HealthCare LLC, Whippany NJ 07981 USA", "Active ingredient": "Miconazole nitrate 2%", "Other information": "store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "Inactive ingredients isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc", "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", "PRINCIPAL DISPLAY PANEL - 133 g Can Label": "Powder Spray goes on dry NDC 11523-4140-2 LOTRIMIN ® AF ANTIFUNGAL miconazole nitrate Clinically Proven To Cure Most Jock Itch Relieves Itching, Burning, Scaling & Chafing NET WT 133g (4.6 OZ)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:38.503867 · Updated: 2026-03-14T23:05:32.543899