Lotrimin ®

Lotrimin ®
SPL v2
SPL
SPL Set ID 163996c6-af54-21ac-e063-6394a90ac05c
Route
TOPICAL
Published
Effective Date 2024-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Starch, Corn Isobutane Stearalkonium Hectorite Hydroxypropyl Cellulose, Unspecified Kaolin Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-26

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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
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 near heat, flame, or while smoking

Warnings

For external use only

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
Questions?

1-866-360-3266 or visit us at www.lotrimin.com

Distribution

Distributed by: Bayer HealthCare LLC, Whippany NJ

Active Ingredient

(To Deliver) Miconazole nitrate 2%

Other Information

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

Inactive Ingredients

hydroxypropyl cellulose, isobutane, kaolin, magnesium stearate, SD alcohol 40-B (8% w/w), 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 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Principal Display Panel 133 G Can Label

Powder Spray

goes on dry TALC FREE

LOTRIMIN ® AF



miconazole nitrate ANTIFUNGAL

Clinically Proven To Cure Most

Athlete's Foot

Relieves

  • Itching
  • Burning
  • Cracking
  • Scaling

NET WT 133g (4.6 OZ)


Structured Label Content

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
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 near heat, flame, or while smoking

Purpose

Antifungal

Warnings

For external use only

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
Questions?

1-866-360-3266 or visit us at www.lotrimin.com

Distribution

Distributed by: Bayer HealthCare LLC, Whippany NJ

Active Ingredient (Active ingredient)

(To Deliver) 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, magnesium stearate, SD alcohol 40-B (8% w/w), 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 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Principal Display Panel 133 G Can Label (PRINCIPAL DISPLAY PANEL - 133 g Can Label)

Powder Spray

goes on dry TALC FREE

LOTRIMIN ® AF



miconazole nitrate ANTIFUNGAL

Clinically Proven To Cure Most

Athlete's Foot

Relieves

  • Itching
  • Burning
  • Cracking
  • Scaling

NET WT 133g (4.6 OZ)


Advanced Ingredient Data


Raw Label Data

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