Lotrimin ®

Lotrimin ®
SPL v9
SPL
SPL Set ID d6eb3b78-405b-43e5-9db5-da671465eda1
Route
TOPICAL
Published
Effective Date 2014-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Dimethyl Ether

Identifiers & Packaging

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 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 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 the contents can be harmful or fatal
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Section 50570-1

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
  • 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

Distribution

Distributed by Bayer HealthCare LLC

Whippany, NJ 07981 USA

Active Ingredient

(To Deliver) Miconazole nitrate 2%

Other Information

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

Inactive Ingredients

dimethyl ether, polyoxyl 15 hydroxystearate, sd alcohol 40-B (16.5% v/v)

Principal Display Panel 133 G Can Label

Liquid Spray



cools the burn

NDC 11523-4327-01

LOTRIMIN ® AF



ANTIFUNGAL



miconazole nitrate

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 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 the contents can be harmful or fatal
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Section 50570-1 (50570-1)

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
  • 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

Distribution

Distributed by Bayer HealthCare LLC

Whippany, NJ 07981 USA

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)

dimethyl ether, polyoxyl 15 hydroxystearate, sd alcohol 40-B (16.5% v/v)

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

Liquid Spray



cools the burn

NDC 11523-4327-01

LOTRIMIN ® AF



ANTIFUNGAL



miconazole nitrate

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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