LOTRIMIN ANTIFUNGAL- miconazole nitrate powder

Lotrimin by

Drug Labeling and Warnings

Lotrimin by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• relieves itching, cracking, burning and scaling

Warnings

For external use only

Avoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• if there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

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

Directions

• wash affected area and dry thoroughly
• sprinkle 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

benzethonium chloride, corn starch, kaolin, sodium bicarbonate, starch/acrylates/acrylamide copolymer, zinc oxide

PRINCIPAL DISPLAY PANEL - 90g Can Label

NDC: 11523-0919-1

LOTRIMIN®AF

ANTIFUNGAL

miconazole nitrate

Cures Most

Athlete's Foot

POWDER

• Absorbs Moisture
• Relieves Itching,
  
  Burning & Scaling

NET WT 90g (3 OZ)

37871-00

INGREDIENTS AND APPEARANCE

LOTRIMIN  ANTIFUNGAL
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0919
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
STARCH, CORN (UNII: O8232NY3SJ)
KAOLIN (UNII: 24H4NWX5CO)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ZINC OXIDE (UNII: SOI2LOH54Z)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0919-1	90 g in 1 CAN; Type 0: Not a Combination Product	09/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/01/1993

Labeler - Bayer HealthCare LLC. (112117283)