Lotrimin ® - DailyMed Details

Lotrimin ®

SPL v2

SPL

SPL Set ID 0c53cf0f-767e-a422-e063-6394a90ab764

Route

TOPICAL

Published

Effective Date 2023-11-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Miconazole (20 mg)

Inactive Ingredients

Stearalkonium Hectorite Starch, Corn Magnesium Stearate Kaolin Isobutane

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-29

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

For external use only

Flammable: DO not use near heat, flame, or while smoking

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

Questions?

1-866-360-3266

Active Ingredient

Miconazole nitrate 2%

Other Information

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

Inactive Ingredients

hydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch

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)

For external use only

Flammable: DO not use near heat, flame, or while smoking

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

Questions?

1-866-360-3266

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)

hydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch

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": "STEARALKONIUM HECTORITE", "unii": "OLX698AH5P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "KAOLIN", "unii": "24H4NWX5CO", "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": "For external use only Flammable: DO not use near heat, flame, or while smoking Do not use on children under 2 years of age unless directed by 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", "Questions?": "1-866-360-3266", "Active ingredient": "Miconazole nitrate 2%", "Other information": "store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "hydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:27.266209 · Updated: 2026-03-14T23:10:55.855807