lotrimin ®

lotrimin ®
SPL v2
SPL
SPL Set ID 0bee54eb-df2f-15fe-e063-6294a90a2fd2
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 hydroxypropyl cellulose, unspecified kaolin isobutane magnesium stearate starch, corn

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-11-29

Purpose

Antifungal

Description

Drug Facts


Medication Information

Warnings

For external use only

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
Purpose

Antifungal

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

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

Description

Drug Facts

Questions?

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

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 50566-9

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)
Section 50567-7

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.
Flammable

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

Active Ingredient

Miconazole nitrate 2%

Principal Display Panel 133 G Can Label

Deodorant Powder Spray



fights odor
. 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

Warnings

For external use only

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
Purpose

Antifungal

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 (Other information)

store between 20° to 25°C 68° to 77°F

Inactive Ingredients (Inactive ingredients)

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

Questions?

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

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 50566-9 (50566-9)

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)
Section 50567-7 (50567-7)

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.
Flammable

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

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

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

Deodorant Powder Spray



fights odor
. 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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